Sacubitril and Valsartan

Product NDC
60687-966
11-digit product format
606870966
Labeler code
60687
Product ID
60687-966_51e0d871-d81f-11e5-e063-6294a90aaec5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sacubitril and Valsartan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA213611
Marketing category
ANDA
Marketing start
2026-05-01
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
17ERJ0MKGISACUBITRIL149709-62-6SACUBITRIL
80M03YXJ7IVALSARTAN137862-53-4VALSARTAN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-966-576068709665760 BLISTER PACK in 1 CARTON (60687-966-57) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-966-11) 60 blister pack2026-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sacubitril and ValsartanAmerican Health Packaging2026-05-15HUMAN PRESCRIPTION DRUG LABEL1