NCD Mental Health Drug specification 2074(Full Descriptions Included)
| Diazepam Tablets 2mg | |
| INN/Generic Name | Diazepam Tablets
|
| Dosage form | Tablets
|
| Strength | Eachtablet contains-
Diazepam 2mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack
|
| Primary Pack | Diazepam tablets should be packed in an Aluminum- amber / opaque PVC film blister pack.
PVC film thickness : NLT 250 micron & NLT 350 gsm.
Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Diazepam tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protected from light .
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Metformin Tablets 850mg | |
| INN/Generic Name | Metformin hydrochloride Tablets
|
| Dosage form | Tablets
|
| Strength | Each tablet contains-
Metformin HCl 850mg.
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack
|
| Primary Pack | 10 Metformin Tablets should be packed in an Aluminum- PVDC coated PVC film blister pack.
PVC film Thickness : NLT 250 micron with 60 gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Metformin tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT5 ply.
|
| Special Storage | Store at room temperature.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Hydrochlorothiazide Tablets 12.5mg | |
| INN/Generic Name | Hydrochlorothiazide Tablets
|
| Dosage form | Tablets
|
| Strength | Each tablet contains-
Hydrochlorothiazide 12.5mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets blister pack
|
| Primary Pack | Hydrochlorothiazide tablets should be packed in an Aluminum- PVC film blister pack.
PVC film thickness : NLT 250 micron & NLT 350 gsm.
Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
|
| Quantity primary pack in supply unit | 10 blisters each containing 10 Hydrochlorothiazide tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Preserve in well closed containers.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store
|
| Enalapril Tablets 2.5 mg | |
| INN/Generic Name | Enalapril Maleate Tablets
|
| Dosage form | Tablets
|
| Strength | Each film coated tablet contains-
Enalapril Maleate 2.5mg.
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack
|
| Primary Pack | Enalapril Tablets should should be packed in an Aluminum-PVDC coated PVC film blister pack.
PVC film thickness : NLT 250 micron with 60 gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Enalapril tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store at room temperature.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| EnalaprilTablets 5 mg | |
| INN/Generic Name | Enalapril Maleate Tablets
|
| Dosage form | Tablets
|
| Strength | Each Film Coated tablet contains-
Enalapril Maleate 5mg.
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack
|
| Primary Pack | Enalapril Tablets should be packed in an Aluminum-PVDC coated PVC film blister pack.
PVC film thickness : NLT 250 micron with 60 gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Enalapril tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store at room temperature.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Risperidone Tablets 1mg | |
| INN/Generic Name | Risperidone Tablet |
| Dosage form | Tablets
|
| Strength | Each Film Coated tablet contains-
Risperidone 1mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack |
| Primary Pack | Risperidone tablets should be packed in an Aluminum- amber / opaque PVC film blister pack.
PVC film thickness : NLT 250 micron & NLT 350 gsm.
Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm. |
| Quantity primary pack in supply unit | 10 blisters each containing 10 Risperidone Tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
|
| Special Storage | Preserve at tight , light resistant containers.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Risperidone Tablets 2 mg | |
| INN/Generic Name | Risperidone Tablet |
| Dosage form | Tablets
|
| Strength | Each Film Coated tablet contains-
Risperidone 2mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack |
| Primary Pack | Risperidone tablets should be packed in an Aluminum- amber/ opaque PVC film blister pack.
PVC film thickness : NLT 250 micron & NLT 350 gsm.
Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm. |
| Quantity primary pack in supply unit | 10 blisters each containing 10 Risperidone Tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
|
| Special Storage | Preserve at tight , light resistant containers.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Fluoxetine Capsules 10mg | |
| INN/Generic Name | Fluoxetine Hydrochloride Capsule, Fluoxetine Capsules |
| Dosage form | Capsules
|
| Strength | Each Capsule contains-
Fluoxetine 10mg
|
| Standard | API should meet the monograph requirement/capsule should meet general requirement stated under capsule and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043 |
| Basic Unit | 1×10 Capsules blister pack. |
| Primary Pack | Fluoxetine Capsules should be packed in an Aluminum- PVDC coated PVC film blister pack.
PVC film thickness : NLT 250 micron with 60gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 blisters each containing 10Fluoxetinecapsules are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protected from moisture. |
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store. |
| Fluoxetine Capsules 20mg | |
| INN/Generic Name | Fluoxetine Hydrochloride Capsule, Fluoxetine Capsules. |
| Dosage form | Capsules
|
| Strength | Each Capsule contains-
Fluoxetine 20mg
|
| Standard | API should meet the monograph requirement/capsule should meet general requirement stated under capsule and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043 |
| Basic Unit | 1×10 Capsules blister pack. |
| Primary Pack | Fluoxetine Capsules should be packed in an Aluminum- PVDC coated PVC film blister pack.
PVC film thickness : NLT 250 micron with 60gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 blisters each containing 10 Fluoxetine capsules are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protected from moisture. |
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store. |
| Sodium Valproate Gastro –Resistant Tablets 200mg | |
| INN/Generic Name | Sodium Valproate Gastro –Resistant Tablets , Gastro – Resistant Sodium Valproate Tablets. |
| Dosage form | Tablets
|
| Strength |
Each enteric coated tablet contains- Sodium Valproate 200mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets strippack |
| Primary Pack | Sodium Valproate Tablets should be packed in an Aluminum-Aluminum Strip pack.
Aluminum foils thickness –NLT 40 micron and 60 gsm.
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Sodium Valproate tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protected from moisture.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Sodium Valproate Gastro –Resistant Tablets 300mg | |
| INN/Generic Name | Sodium Valproate Gastro –Resistant Tablets , Gastro – Resistant Sodium Valproate Tablets |
| Dosage form | Tablets
|
| Strength | Each enteric coated tablet contains-
Sodium Valproate 300mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack |
| Primary Pack | Sodium Valproate Tablets should be packed in an Aluminum-Aluminum Strip pack.
Aluminum foils thickness –NLT 40 micron and 60 gsm. |
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Sodium valproate tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protected from moisture .
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Trihexiphenidyl Tablet 2mg | |
| INN/Generic Name | Trihexyphenidyl Hydrochloride Tablet |
| Dosage form |
Tablet |
| Strength | Each tablet contains-
TrihexyphenidylHCl 2mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack |
| Primary Pack | Trihexyphenidyl tablets should be packed in an Aluminum- PVDC coated amber / opaque PVC film blister pack.
PVC film thickness : NLT 250 micron with 60gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Trihexyphenidyl tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Preserve in tight containers.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
| Thiamine tablet 100mg | |
| INN/Generic Name | Thiamine Hydrochloride Tablet |
| Dosage form | Tablets
|
| Strength | Each tablet contains-
Thiamine hydrochloride 100mg
|
| Standard | API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
|
| Basic Unit | 1×10 Tablets Blister pack |
| Primary Pack | Thiamine Tablets should be packed in an Aluminum- PVDC coated amber colored / opaque PVC film blister pack.
PVC film thickness : NLT 250 micron with 60gsm PVDC coating
Aluminum Foil Thickness : NLT 25 micron
|
| Quantity primary pack in supply unit | 10 Blisters each containing 10 Thiamine tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
|
| Special Storage | Store protrected from light and moisture in non metalic containers.
|
| Shelf Life | Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
|
Sources : WHO/MoHP Nepal
Discussion about this post