NDC 52276-312

Carbaglu

Carglumic Acid

Carbaglu is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases. The primary component is Carglumic Acid.

• Product ID: 52276-312_2214969d-cb0e-438d-b329-c78e72d0198b
• NDC: 52276-312
• Product Type: Human Prescription Drug
• Proprietary Name: Carbaglu
• Generic Name: Carglumic Acid
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-03-18
• Marketing Category: NDA / NDA
• Application Number: NDA022562
• Labeler Name: Recordati Rare Diseases
• Substance Name: CARGLUMIC ACID
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Carbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 52276-312-05

5 TABLET in 1 BOTTLE (52276-312-05)

• Marketing Start Date: 2010-03-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52276-312-60 [52276031260]

Carbaglu TABLET

• Marketing Category: NDA
• Application Number: NDA022562
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-03-18

NDC 52276-312-05 [52276031205]

Carbaglu TABLET

• Marketing Category: NDA
• Application Number: NDA022562
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-03-18

Drug Details

Active Ingredients

Ingredient	Strength
CARGLUMIC ACID	200 mg/1

OpenFDA Data

• SPL SET ID: 10175e73-5172-4dde-a508-8a88b7afc0a1
• Manufacturer:
  • Orphan Europe, SARL
• UNII:
  • 5L0HB4V1EW
• RxNorm Concept Unique ID - RxCUI:
  • 905390
  • 905394
• UPC Code:
  • 9317935240809

Pharmacological Class

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

NDC Crossover Matching brand name "Carbaglu" or generic name "Carglumic Acid"

NDC	Brand Name	Generic Name
52276-312	Carbaglu	Carglumic Acid
35573-459	Carglumic acid	Carglumic acid
68475-006	Carglumic acid	Carglumic acid
70954-120	Carglumic Acid	Carglumic Acid
71863-114	Carglumic Acid	Carglumic Acid