PHENOBARBITAL
PHENOBARBITAL TABLETS, USP C-IVRx only
Approved
Approval ID
7e6853a4-478d-40e3-b041-4cff02a74c8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
Manufacturers
FDA
QUAGEN PHARMACEUTICALS LLC
DUNS: 073645339
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 Code70752-161
Product Classification
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70752-164
Product Classification
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 97.2 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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70752-163
Product Classification
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 64.8 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70752-162
Product Classification
G
Generic Name
PHENOBARBITAL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 32.4 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT