Carglumic acid NDC 35573-459

NDC codes

FDA NDC Directory

Product NDC (as listed)35573-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35573-0459Add 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
35573-459-60	35573045960	60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60)Marketed from Dec 19, 2022

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): Carglumic acid
Generic name (nonproprietary): carglumic acid
Active ingredients: Carglumic acid — 200 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Burel Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213395
Marketing start: Dec 19, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Carbamoyl Phosphate Synthetase 1 Activators (Mechanism)
Identifiers: Product ID 35573-459_28393de7-fa10-4e7d-919e-4d0b19c888a1SPL ID 28393de7-fa10-4e7d-919e-4d0b19c888a1SPL set ID 2aee4281-402b-4cd6-9e6a-08945262e1a1RxCUI 905390UNII 5L0HB4V1EWUPC 0335573459604
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

N435573045960 followed by a unit qualifier and the quantity

Package 35573-0459-60. 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 Mar 19, 2024.

Indications (excerpt from the label)

Carglumic acid tablets for oral suspension 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 ) 1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension is indicated in adult and pediatric patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency. Maintenance therapy for the tre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213395

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213395
Product	Strength	Form · route	Labeler	Product NDC
Carglumic acid	Carglumic acid 200 mg/1	Tablet, For suspensionOral	Navinta LLC	68475-006