sacubitril and valsartan
- Product NDC
- 70710-1274
- 11-digit product format
- 707101274
- Labeler code
- 70710
- Product ID
- 70710-1274_581c1ab7-7950-4524-a47a-de378f5ee9ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sacubitril and valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA213719
- Marketing category
- ANDA
- Marketing start
- 2025-07-08
- Substance
- SACUBITRIL; VALSARTAN
- Active strength
- 97; 103 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 17ERJ0MKGI | SACUBITRIL | 149709-62-6 | SACUBITRIL |
| 80M03YXJ7I | VALSARTAN | 137862-53-4 | VALSARTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1274-4 | 70710127404 | 10 BLISTER PACK in 1 CARTON (70710-1274-4) / 10 TABLET in 1 BLISTER PACK (70710-1274-2) | 10 blister pack | 2025-07-08 | No | No | Historical |
| 70710-1274-6 | 70710127406 | 60 TABLET in 1 BOTTLE (70710-1274-6) | 60 tablet | 2025-07-08 | No | No | Historical |
| 70710-1274-8 | 70710127408 | 180 TABLET in 1 BOTTLE (70710-1274-8) | 180 tablet | 2025-07-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| sacubitril and valsartan | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-07-08 | HUMAN PRESCRIPTION DRUG LABEL | 2 |