Sodium Phenylacetate and sodium benzoate NDC 68475-001

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0001Add 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
68475-001-50	68475000150	1 VIAL in 1 CARTON (68475-001-50) / 50 mL in 1 VIALMarketed from Mar 4, 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): Sodium Phenylacetate and sodium benzoate
Generic name (nonproprietary): sodium phenylacetate and sodium benzoate
Active ingredients: Sodium phenylacetate — 100 mg/mLSodium benzoate — 100 mg/mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205880
Marketing start: Mar 4, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 68475-001_e2b1772b-057e-4c1a-a3e1-6bbf7c2d770eSPL ID e2b1772b-057e-4c1a-a3e1-6bbf7c2d770eSPL set ID fbc7bfe3-6faa-45a3-befb-9ad7963c0571RxCUI 984118UNII 48N6U1781G, OJ245FE5EUUPC 0368475001503
Pharmacologic class: Nitrogen Binding Agent

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468475000150 followed by a unit qualifier and the quantity

Package 68475-0001-50. 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 Sep 30, 2024.

Indications (excerpt from the label)

Sodium phenylacetate and sodium benzoate injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. (1) Sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [ see Warning…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205880

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

FDA NDC Directory listings under ANDA 205880
Product	Strength	Form · route	Labeler	Product NDC
Sodium Phenylacetate And Sodium Benzoate	Sodium phenylacetate 100 mg/mL; Sodium benzoate 100 mg/mL	Injection, Solution, ConcentrateIntravenous	Zydus Pharmaceuticals USA Inc.	68382-396