Carglumic acid NDC 68475-006

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-006Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0006Add 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
68475-006-01	68475000601	5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)Marketed from Aug 1, 2022
68475-006-02	68475000602	60 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02)Marketed from Aug 1, 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: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213395
Marketing start: Aug 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Carbamoyl Phosphate Synthetase 1 Activators (Mechanism)
Identifiers: Product ID 68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40SPL ID 55e79bd0-56bd-4095-aa7e-942b3e5c1b40SPL set ID 59e73eb8-edf8-4fad-93c2-deb6b23497f8RxCUI 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

N468475000601 followed by a unit qualifier and the quantity

Package 68475-0006-01. 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 23, 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…

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	Burel Pharmaceuticals, LLC	35573-459