Prescription drug · ANDA
Bosentan NDC 68180-340
Bosentan 32 mg/1 · Tablet, For suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-340-13 | 68180034013 | 4 BLISTER PACK in 1 CARTON (68180-340-13) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACKMarketed from Aug 18, 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)
- Bosentan
- Generic name (nonproprietary)
- bosentan
- Active ingredients
- Bosentan — 32 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213154
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68180-340_063d2028-f666-4304-8cd3-21d882d8c97fSPL ID 063d2028-f666-4304-8cd3-21d882d8c97fSPL set ID 540b6f6a-79f3-4681-8c2a-268cf7cecbc9RxCUI 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
N468180034013followed by a unit qualifier and the quantityPackage 68180-0340-13. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1) ] . in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in …
Excerpt only. Read the full label for complete information.