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
NDC Product Code70752-161
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
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
NDC Product Code70752-164
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
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
NDC Product Code70752-163
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
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
NDC Product Code70752-162
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
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