Phenobarbital
PHENOBARBITAL TABLETS, USP CIV Rx only
Approved
Approval ID
746d5afa-d2f2-475f-b318-d4003c6d6924
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2023
Manufacturers
FDA
ECI Pharmaceuticals, LLC
DUNS: 962476029
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 Code51293-625
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
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
PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-627
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 64.8 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
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-626
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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 Code51293-628
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENOBARBITALActive
Quantity: 97.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT