PHENOBARBITAL
PHENOBARBITAL TABLETS, USP C-IVRx only
Approved
Approval ID
81930c69-d073-402a-9089-ae891bfddc25
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 Code70752-167
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 60 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
PRODUCT DETAILS
NDC Product Code70752-165
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 15 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
PHENOBARBITAL
PRODUCT DETAILS
NDC Product Code70752-166
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITALActive
Quantity: 30 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
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 Code70752-168
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateFebruary 16, 2023
Generic NamePHENOBARBITAL
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PHENOBARBITALActive
Quantity: 100 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT