Prescription drug · ANDA
Selexipag TITRATION PACK (Selexipag) NDC 70710-1653
Kit · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1653-7 | 70710165307 | 1 KIT in 1 CARTON (70710-1653-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6)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 Pharmaceuticals (USA) Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214302
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1653_96a3e445-2cb7-4fb5-b95b-3f71f5f72504SPL ID 96a3e445-2cb7-4fb5-b95b-3f71f5f72504SPL set ID c604e181-e336-4194-bf96-f65dd164d461RxCUI 1729007, 1729027, 1729031, 1729045, 1729051, 1729055, 1729059, 1729063, 1729075UNII 5EXC0E384LUPC 0370710155766, 0370710155469, 0370710155360, 0370710155667, 0370710155261, 0370710155865, 0370710155568, 0370710155162
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
N470710165307followed by a unit qualifier and the quantityPackage 70710-1653-07. 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 70710-1653
- What is NDC 70710-1653?
- 70710-1653 is the product NDC for Selexipag TITRATION PACK (selexipag) kit, 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?
- Selexipag TITRATION PACK (Selexipag).
- 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 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 Lifesciences Limited | 70771-1801 | 70771-1801-07 |
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 Lifesciences Limited | 70771-1801 |