Sacubitril and valsartan
- Product NDC
- 31722-675
- 11-digit product format
- 317220675
- Labeler code
- 31722
- Product ID
- 31722-675_3a93c356-cfa8-4c31-e063-6394a90a536a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA213668
- Marketing category
- ANDA
- Marketing start
- 2025-07-23
- 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 |
|---|
| 31722-675-18 | Sacubitril and valsartan | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
| 31722-675-60 | Sacubitril and valsartan | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-675-18 | 31722067518 | 180 TABLET, FILM COATED in 1 BOTTLE (31722-675-18) | 2025-07-23 | No | No | Current |
| 31722-675-60 | 31722067560 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-675-60) | 2025-07-23 | No | No | Current |