Prescription drug · ANDA
Sodium phenylbutyrate NDC 70710-2180
Sodium phenylbutyrate 500 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2180-8 | 70710218008 | 1 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLEMarketed from Mar 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 phenylbutyrate
- Generic name (nonproprietary)
- sodium phenylbutyrate
- Active ingredients
- Sodium phenylbutyrate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220418
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 70710-2180_47ef97e0-8853-4254-b969-1a489764cec1SPL ID 47ef97e0-8853-4254-b969-1a489764cec1SPL set ID d08fd548-7eb8-4f6f-b664-b0fff6f30065RxCUI 199369UNII NT6K61736TUPC 0370710218089
- 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 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
N470710218008followed by a unit qualifier and the quantityPackage 70710-2180-08. 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)
INDICATIONS AND USAGE Sodium phenylbutyrate tablets are indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately t…
Excerpt only. Read the full label for complete information.
About NDC 70710-2180
- What is NDC 70710-2180?
- 70710-2180 is the product NDC for Sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium phenylbutyrate.
- What is the active ingredient?
- Sodium phenylbutyrate.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium phenylbutyrate?
- 4 other product NDCs are listed under this name. See all Sodium phenylbutyrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium phenylbutyrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | Navinta LLC | 68475-011 | 68475-0011-01 |
| sodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | GLENMARK PHARMACEUTICALS INC., USA | 68462-853 | 68462-0853-20 |
| Sodium Phenylbutyrate | Sodium phenylbutyrate .94 g/g | PowderOral | Par Health USA, LLC | 49884-006 | 49884-0006-04 |
| Sodium Phenylbutyratesodium phenylbutyrate tablets, 500 mg | Sodium phenylbutyrate 500 mg/1 | TabletOral | Par Health USA, LLC | 49884-170 | 49884-0170-04 |
Other NDCs under ANDA 220418
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 phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | Navinta LLC | 68475-011 |