What is NDC 52276-312?

52276-312 is the product NDC for Carbaglu (carglumic acid), Carglumic acid 200 mg/1 tablet, for suspension, listed with the FDA by Recordati Rare Diseases. It has 2 package NDCs, shown above in 10- and 11-digit form.

Recordati Rare Diseases, NDC labeler code 52276. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carbaglu?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carbaglu NDC 52276-312 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52276-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52276-0312Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
52276-312-05	5227603120552276031205	5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05)Marketed from Mar 18, 2010
52276-312-60	5227603126052276031260	60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60)Marketed from Mar 18, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Carbaglu
Generic name (nonproprietary): carglumic acid
Active ingredients: Carglumic acid — 200 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Recordati Rare DiseasesNDC labeler code 52276
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022562
Marketing start: Mar 18, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Carbamoyl Phosphate Synthetase 1 Activators (Mechanism)
Identifiers: Product ID 52276-312_7238020c-dcef-42ca-947b-6162e1488608SPL ID 7238020c-dcef-42ca-947b-6162e1488608SPL set ID 10175e73-5172-4dde-a508-8a88b7afc0a1RxCUI 905390, 905394UNII 5L0HB4V1EW
Pharmacologic class: Carbamoyl Phosphate Synthetase 1 Activator

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N452276031205 followed by a unit qualifier and the quantity

Package 52276-0312-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 25, 2024.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE CARBAGLU is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ( 1.1 ) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. ( 1.1 ) Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA). ( 1.2 ) 1.1 Acute and Chronic Hyperammonemia due to N‑acetylglutamate Synthase (NAGS) Deficiency CARBAGLU is indicated in adult and pediatric patients as: Adjunctive therapy to stan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52276-312

What is NDC 52276-312?: 52276-312 is the product NDC for Carbaglu (carglumic acid), Carglumic acid 200 mg/1 tablet, for suspension, listed with the FDA by Recordati Rare Diseases. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carbaglu (Carglumic Acid).
What is the active ingredient?: Carglumic acid.
Who is the labeler?: Recordati Rare Diseases, NDC labeler code 52276. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carbaglu?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Carbaglu (Carglumic acid) NDC 52276-312