Prescription drug · ANDA
SODIUM PHENYLACETATE and SODIUM BENZOATE NDC 81665-203
Sodium phenylacetate 100 mg/mL; Sodium benzoate 100 mg/mL · Injection, Solution, Concentrate · Intravenous · Omnivium Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-203-01 | 81665020301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 25, 2025 |
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
- Omnivium Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207096
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 81665-203_ab598188-342a-419e-9471-a7b60a25b198SPL ID ab598188-342a-419e-9471-a7b60a25b198SPL set ID 9067c301-74f9-457a-9b0f-b7e9b06a3508RxCUI 984118UNII 48N6U1781G, OJ245FE5EU
- 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.
- NDC on a medical claim
N481665020301followed by a unit qualifier and the quantityPackage 81665-0203-01. 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 .
Indications (excerpt from the label)
Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% 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 Warnings and Precautions (5) ]. Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with defic…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207096
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Omnivium Pharmaceuticals LLC | 81665-204 |
| SODIUM PHENYLACETATE and SODIUM BENZOATE | Sodium phenylacetate 100 mg/mL; Sodium benzoate 100 mg/mL | Injection, Solution, ConcentrateIntravenous | Ailex Pharmaceuticals, LLC | 70556-100 |