Sacubitril and Valsartan
- Product NDC
- 43598-644
- 11-digit product format
- 435980644
- Labeler code
- 43598
- Product ID
- 43598-644_2745b697-4155-c757-7e40-826bf72e469d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sacubitril and Valsartan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213627
- Marketing category
- ANDA
- Marketing start
- 2025-07-16
- Substance
- SACUBITRIL; VALSARTAN
- Active strength
- 49; 51 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 17ERJ0MKGI | SACUBITRIL | 149709-62-6 | SACUBITRIL |
| 80M03YXJ7I | VALSARTAN | 137862-53-4 | VALSARTAN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-644-18 | 43598064418 | 180 TABLET, FILM COATED in 1 BOTTLE (43598-644-18) | 2025-07-16 | No | No | Historical |
| 43598-644-60 | 43598064460 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-644-60) | 2025-07-16 | No | No | Historical |