Ibuprofen Lysine

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

Company

DUNS: 065969375

Effective Date

January 5, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ibuprofen(10 mg in 1 mL)

Manufacturing Establishments1

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

Labeler

Prasco Laboratories

DUNS Number

832394733

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

NDC Product Code

66993-490

Application Number

NDA021903

Marketing Category

NDA authorized generic (C73605)

Route of Administration

INTRAVENOUS

Effective Date

October 31, 2023

Ingredients

Code: N01ORX9D6SClass: ACTIMQuantity: 10 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT