Phenobarbital
Phenobarbital Tablets, USP CIVRx only
Approved
Approval ID
069b92ce-0061-4724-8c25-08d8596770a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code0603-5166
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITALActive
Quantity: 32.4 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5167
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (6)
PHENOBARBITALActive
Quantity: 64.8 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
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5168
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PHENOBARBITALActive
Quantity: 97.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5165
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT