sacubitril and valsartan
- Product NDC
- 67046-1624
- 11-digit product format
- 670461624
- Labeler code
- 67046
- Product ID
- 67046-1624_48c0e508-e68a-3d43-e063-6294a90a3ade
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sacubitril and valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA213682
- Marketing category
- ANDA
- Marketing start
- 2025-12-16
- Substance
- SACUBITRIL; VALSARTAN
- Active strength
- 24; 26 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 | 24 mg/1 |
| VALSARTAN | 26 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 17ERJ0MKGI, 80M03YXJ7I |
| Rxcui | 1656340 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1624-3 | sacubitril and valsartan | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1624-3 | 67046162403 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1624-3) | 2025-12-16 | No | No | Historical |