Phenobarbital
PHENOBARBITAL TABLETS, USP CIV Rx only
Approved
Approval ID
8483f082-131d-4218-81d7-61c716af65b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Clinical Solutions Wholesale, LLC
DUNS: 078710347
Products 1
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 Code58118-1626
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PHENOBARBITALActive
Quantity: 32.4 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB