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Phenobarbital

PHENOBARBITAL TABLETS, USP CIV Rx only

Approved
Approval ID

bff7c483-be72-4286-a080-0b5f5d7430ba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2023

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 Code72162-1582
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENOBARBITALActive
Quantity: 30 mg in 1 1
Code: YQE403BP4D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Phenobarbital - FDA Drug Approval Details