Phenobarbital
PHENOBARBITAL TABLETS, USP CIVRx only
Approved
Approval ID
ac57a37d-79ae-49b4-a5e5-b6f03481a225
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2022
Manufacturers
FDA
ECI Pharmaceuticals, LLC
DUNS: 962476029
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-694
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2020
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PHENOBARBITALActive
Quantity: 100 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-692
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2020
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 30 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-691
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2020
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 15 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-693
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2020
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 60 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT