Sacubitril and Valsartan
- Product NDC
- 0904-7581
- 11-digit product format
- 009047581
- Labeler code
- 0904
- Product ID
- 0904-7581_f2cba3db-0256-422a-a8a4-7afb3a9970d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA213764
- Marketing category
- ANDA
- Marketing start
- 2025-11-03
- 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
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 | 97 mg/1 |
| VALSARTAN | 103 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 17ERJ0MKGI, 80M03YXJ7I |
| Rxcui | 1656340, 1656349, 1656354 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7581-04 | Sacubitril and Valsartan | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 1 |
| 0904-7581-04 | Sacubitril and Valsartan | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 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 |
|---|
| 0904-7581-04 | 00904758104 | 30 BLISTER PACK in 1 CARTON (0904-7581-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2025-11-03 | No | No | Current |