Prescription drug · ANDA
bosentan NDC 70771-1908
Bosentan 32 mg/1 · Tablet, For suspension · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1908-8 | 70771190808 | 4 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7)Marketed from Feb 17, 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)
- bosentan
- Generic name (nonproprietary)
- bosentan
- Active ingredients
- Bosentan — 32 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213981
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1908_008fc213-caa0-4d52-9ee2-e3628c19b90bSPL ID 008fc213-caa0-4d52-9ee2-e3628c19b90bSPL set ID b88cc559-93ae-42db-9c38-fb5e9c4802e6RxCUI 1989081UNII Q326023R30
- Pharmacologic class
- Endothelin Receptor Antagonist
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
N470771190808followed by a unit qualifier and the quantityPackage 70771-1908-08. 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 .
Other NDCs under ANDA 213981
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 |
|---|---|---|---|---|
| bosentan | Bosentan 32 mg/1 | Tablet, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1508 |