Carglumic Acid NDC 71863-114

NDC codes

FDA NDC Directory

Product NDC (as listed)71863-114Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71863-0114Add 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
71863-114-60	71863011460	1 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLEMarketed from Dec 20, 2021

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: Eton Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213729
Marketing start: Dec 20, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Carbamoyl Phosphate Synthetase 1 Activators (Mechanism)
Identifiers: Product ID 71863-114_ce6d0fd4-bbe0-4a22-bfb5-33326b63a67fSPL ID ce6d0fd4-bbe0-4a22-bfb5-33326b63a67fSPL set ID 591f95ca-3d99-4fb6-a402-e5a383a746d0RxCUI 905390UNII 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

N471863011460 followed by a unit qualifier and the quantity

Package 71863-0114-60. 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 3, 2026.

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 are 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 treatm…

Excerpt only. Read the full label for complete information.

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