35573-459 : Carglumic Acid 200 mg Oral Tablet, for Suspension


NDC: 35573-459
Labeler: Burel Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name:  Carglumic Acid
Dosage Form: Oral Tablet, for Suspension
Application #: ANDA213395
Rev. Date: 


NDC Package Codes:

  • 35573-459-60: 60 TABLET, FOR SUSPENSION IN 1 BOTTLE (35573‑459‑60)

Active Ingredients:

  • Carglumic Acid

Dosage Strength:

  • 200 mg

Pharmaceutical Classes:

  • Carbamoyl Phosphate Synthetase 1 Activator [EPC]
  • Carbamoyl Phosphate Synthetase 1 Activators [MoA]

Related Products:

Based on records with the same trade name.
  • 68475-006 Carglumic Acid 200 mg Oral Tablet, for Suspension by Navinta LLC
  • 70954-120 Carglumic Acid 200 mg Oral Tablet, for Suspension by Novitium Pharma LLC
  • 71863-114 Carglumic Acid 200 mg Oral Tablet, for Suspension by Eton Pharmaceuticals, Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.