Hydrocodone Bitartrate and Acetaminophen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 828374897

Effective Date

January 21, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocodone(10 mg in 1 1)

Acetaminophen(325 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

RedPharm Drug, Inc.

DUNS Number

828374897

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

67296-1571

Application Number

ANDA202214

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 21, 2022

Ingredients

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1