MedPath

Phenobarbital

PHENOBARBITAL TABLETS, USP C-IV Rx only WARNING: MAY BE HABIT-FORMING

Approved
Approval ID

ee6c3196-becf-439d-9e22-70d82bd94365

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2024

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-2400
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2020
FDA Product Classification

INGREDIENTS (6)

PHENOBARBITALActive
Quantity: 16.2 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Phenobarbital - FDA Drug Approval Details