Sacubitril and Valsartan
- Product NDC
- 71610-984
- 11-digit product format
- 716100984
- Labeler code
- 71610
- Product ID
- 71610-984_487103c6-3587-79ba-e063-6294a90a535f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA213728
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sacubitril and Valsartan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SACUBITRIL | 97 mg/1 |
| VALSARTAN | 103 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 17ERJ0MKGI, 80M03YXJ7I |
| Rxcui | 1656354 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-984-37 | Sacubitril and Valsartan | 3120 in 1 BOTTLE | TABLET | 3120 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-984-37 | 71610098437 | 3120 TABLET in 1 BOTTLE (71610-984-37) | 3120 tablet | 2026-01-14 | No | No | Historical |