Sacubitril and Valsartan
- Product NDC
- 71610-939
- 11-digit product format
- 716100939
- Labeler code
- 71610
- Product ID
- 71610-939_3dd750a5-346a-e671-e063-6394a90a9cf4
- 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
- 49; 51 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sacubitril and Valsartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SACUBITRIL | 49 mg/1 |
| VALSARTAN | 51 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 17ERJ0MKGI, 80M03YXJ7I |
| Rxcui | 1656349 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-939-32 | Sacubitril and Valsartan | 780 in 1 BOTTLE | TABLET, FILM COATED | 780 | | 2 |
| 71610-939-89 | Sacubitril and Valsartan | 720 in 1 BOTTLE | TABLET, FILM COATED | 720 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-939-32 | 71610093932 | 780 TABLET, FILM COATED in 1 BOTTLE (71610-939-32) | 2025-09-02 | No | No | Historical |
| 71610-939-89 | 71610093989 | 720 TABLET, FILM COATED in 1 BOTTLE (71610-939-89) | 2025-08-21 | No | No | Historical |