Sacubitril and Valsartan
- Product NDC
- 71610-955
- 11-digit product format
- 716100955
- Labeler code
- 71610
- Product ID
- 71610-955_4134b078-47c2-9e82-e063-6294a90aaaee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA213748
- Marketing category
- ANDA
- Marketing start
- 2025-01-21
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-955-19 | 71610095519 | 3060 TABLET, FILM COATED in 1 BOTTLE (71610-955-19) | 2025-10-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sacubitril and Valsartan | Aphena Pharma Solutions - Tennessee, LLC | 2025-10-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |