Prescription drug · ANDA
Selexipag TITRATION PACK (Selexipag) NDC 70771-1801
Kit · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1801-7 | 70771180107 | 1 KIT in 1 CARTON (70771-1801-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70771-1793-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70771-1796-6)Marketed from Feb 14, 2025 |
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)
- Selexipag TITRATION PACK
- Generic name (nonproprietary)
- selexipag
- Dosage form
- Kit
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214302
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1801_e39f2aba-4f8f-49d0-82e2-ee509b830d36SPL ID e39f2aba-4f8f-49d0-82e2-ee509b830d36SPL set ID ff660787-880f-4f2b-baac-fd2dbfcd79c2RxCUI 1729007, 1729027, 1729031, 1729045, 1729051, 1729055, 1729059, 1729063, 1729075UNII 5EXC0E384LUPC 0370771179763, 0370771179466, 0370771180066, 0370771179664, 0370771179862, 0370771179565, 0370771179367, 0370771179961
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.
- NDC on a medical claim
N470771180107followed by a unit qualifier and the quantityPackage 70771-1801-07. 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)
Selexipag tablets are a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of selexipag tablets was established in a long-term study in PAH patients with WHO Functional Class II-III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenita…
Excerpt only. Read the full label for complete information.
About NDC 70771-1801
- What is NDC 70771-1801?
- 70771-1801 is the product NDC for Selexipag TITRATION PACK (selexipag) kit, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Selexipag TITRATION PACK (Selexipag).
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Selexipag TITRATION PACK?
- 1 other product NDC are listed under this name. See all Selexipag TITRATION PACK NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Selexipag TITRATION PACK products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Selexipag TITRATION PACKselexipag | — | Kit | Zydus Pharmaceuticals (USA) Inc. | 70710-1653 | 70710-1653-07 |
Other NDCs under ANDA 214302
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 |
|---|---|---|---|---|
| Selexipag | Selexipag 200 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1551 |
| Selexipag | Selexipag 400 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1552 |
| Selexipag | Selexipag 600 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1553 |
| Selexipag | Selexipag 800 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1554 |
| Selexipag | Selexipag 1000 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1555 |
| Selexipag | Selexipag 1200 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1556 |
| Selexipag | Selexipag 1400 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1557 |
| Selexipag | Selexipag 1600 ug/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1558 |
| Selexipag | Selexipag 200 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1793 |
| Selexipag | Selexipag 400 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1794 |
| Selexipag | Selexipag 600 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1795 |
| Selexipag | Selexipag 800 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1796 |
| Selexipag | Selexipag 1000 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1797 |
| Selexipag | Selexipag 1200 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1798 |
| Selexipag | Selexipag 1400 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1799 |
| Selexipag | Selexipag 1600 ug/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1800 |
| Selexipag TITRATION PACKselexipag | — | Kit | Zydus Pharmaceuticals (USA) Inc. | 70710-1653 |