ENTRESTO
- Product NDC
- 0078-1238
- 11-digit product format
- 000781238
- Labeler code
- 0078
- Product ID
- 0078-1238_a0cb416b-6ead-4623-949b-ee3d9dd1143a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- PELLET
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA218591
- Marketing category
- NDA
- Marketing start
- 2024-04-12
- Substance
- SACUBITRIL; VALSARTAN
- Active strength
- 15; 16 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 |
|---|
| 0078-1238-20 | 00078123820 | 60 PELLET in 1 BOTTLE (0078-1238-20) | 60 pellet | 2024-04-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ENTRESTO | Novartis Pharmaceuticals Corporation | 2025-10-29 | HUMAN PRESCRIPTION DRUG LABEL | 24 |
| ENTRESTO | Novartis Pharmaceuticals Corporation | 2025-08-12 | HUMAN PRESCRIPTION DRUG LABEL | 23 |