Sacubitril and Valsartan

Product NDC: 43598-643
11-digit product format: 435980643
Labeler code: 43598
Product ID: 43598-643_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: 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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 43598-643_2745b697-4155-c757-7e40-826bf72e469d
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Sacubitril and Valsartan
Brand name suffix: Sacubitril and Valsartan
Generic name: Sacubitril and Valsartan
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2025-07-16
Marketing category: ANDA
Application number: ANDA213627
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]; Neprilysin Inhibitor [EPC]; Neprilysin Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
SACUBITRIL	24 mg/1
VALSARTAN	26 mg/1

UNII	Preferred term	Registry number	Matched term
17ERJ0MKGI	SACUBITRIL	149709-62-6	SACUBITRIL
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
43598-643-18	43598064318	180 TABLET, FILM COATED in 1 BOTTLE (43598-643-18)	2025-07-16	No	No	Current
43598-643-60	43598064360	60 TABLET, FILM COATED in 1 BOTTLE (43598-643-60)	2025-07-16	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Sacubitril and Valsartan Sacubitril and Valsartan	Dr. Reddy's Laboratories Inc. \| Dr. Reddy's Laboratories Limited	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	9