Phenobarbital
PHENOBARBITAL TABLETS, USP CIV Rx Only Rev. Jan 2022
Approved
Approval ID
1805bc08-e870-4373-b290-bed1eed87df6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2022
Manufacturers
FDA
WINDER LABORATORIES, LLC
DUNS: 965195170
Products 8
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 Code75826-139
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITALActive
Quantity: 32.4 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-143
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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 Code75826-138
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITALActive
Quantity: 30 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-142
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITALActive
Quantity: 97.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-137
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-140
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
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
PHENOBARBITALActive
Quantity: 60 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-136
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 15 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
Phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75826-141
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PHENOBARBITALActive
Quantity: 64.8 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB