Sacubitril and Valsartan
- Product NDC
- 69238-2733
- 11-digit product format
- 692382733
- Labeler code
- 69238
- Product ID
- 69238-2733_fc1d1a2c-611d-4238-b421-49f3887e880c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA213605
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- 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 |
|---|
| 69238-2733-1 | Sacubitril and Valsartan | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 69238-2733-2 | Sacubitril and Valsartan | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69238-2733-1 | 69238273301 | 60 TABLET, FILM COATED in 1 BOTTLE (69238-2733-1) | 2025-06-02 | No | No | Historical |
| 69238-2733-2 | 69238273302 | 180 TABLET, FILM COATED in 1 BOTTLE (69238-2733-2) | 2025-06-02 | No | No | Historical |