Sacubitril and Valsartan
- Product NDC
- 82293-027
- 11-digit product format
- 822930027
- Labeler code
- 82293
- Product ID
- 82293-027_4d34c331-a1f9-937a-e063-6294a90a66b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novugen Pharma (USA) LLC
- Application
- ANDA213611
- Marketing category
- ANDA
- Marketing start
- 2025-07-16
- 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, 1656349, 1656354 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82293-027-10 | Sacubitril and Valsartan | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 82293-027-20 | Sacubitril and Valsartan | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 2 |
| 82293-027-30 | Sacubitril and Valsartan | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 2 |
| 82293-027-31 | Sacubitril and Valsartan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82293-027-10 | 82293002710 | 60 TABLET, FILM COATED in 1 BOTTLE (82293-027-10) | | 2025-07-16 | No | No | Current |
| 82293-027-20 | 82293002720 | 180 TABLET, FILM COATED in 1 BOTTLE (82293-027-20) | | 2025-07-16 | No | No | Current |
| 82293-027-30 | 82293002730 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-027-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-027-31) | 100 blister pack | 2025-07-16 | No | No | Current |
| 82293-027-31 | 82293002731 | 10 in 1 BLISTER PACK | | | | | Historical |