Betaine Anhydrous for Oral Solution

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

Company

DUNS: 081507685

Effective Date

November 10, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Betaine(1 g in 1 g)

Manufacturing Establishments1

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

Labeler

OAKRUM PHARMA, LLC

DUNS Number

080301870

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

NDC Product Code

72647-900

Application Number

ANDA214864

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 10, 2022

Ingredients

Code: 3SCV180C9WClass: ACTIBQuantity: 1 g in 1 g