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Phenobarbital

PHENOBARBITAL ORAL SOLUTION, USP CIV

Approved
Approval ID

ac26cd10-8f66-4254-957c-87a909b576f8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 18, 2023

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP

DUNS: 047437707

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 Code17856-0678
Product Classification
G
Generic Name
Phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2023
FDA Product Classification

INGREDIENTS (7)

PhenobarbitalActive
Quantity: 20 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB
OrangeInactive
Code: 5EVU04N5QU
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
FD&C Red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

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Phenobarbital - FDA Drug Approval Details