Selexipag
- Product NDC
- 70710-1558
- 11-digit product format
- 707101558
- Labeler code
- 70710
- Product ID
- 70710-1558_96a3e445-2cb7-4fb5-b95b-3f71f5f72504
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Selexipag
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA214302
- Marketing category
- ANDA
- Marketing start
- 2025-02-14
- Substance
- SELEXIPAG
- Active strength
- 1600 ug/1
- Pharmacologic classes
- Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Selexipag
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SELEXIPAG | 1600 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5EXC0E384L |
| Rxcui | 1729007, 1729027, 1729031, 1729045, 1729051, 1729055, 1729059, 1729063, 1729075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1558-6 | Selexipag | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1558 | SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, 1 package rows | 20250215_c604e181-e336-4194-bf96-f65dd164d461.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1558-6 | 70710155806 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1558-6) | 2025-02-14 | Yes | No | Current |