SACUBITRIL AND VALSARTAN tablet

sacubitril and valsartan by

Drug Labeling and Warnings

sacubitril and valsartan by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1921-6

Sacubitril and valsartan tablets, 24 mg/26 mg

60 Tablets

Rx only

NDC: 70771-1922-6

Sacubitril and valsartan tablets, 49 mg/51 mg

60 Tablets

Rx only

NDC: 70771-1923-6

Sacubitril and valsartan tablets, 97 mg/103 mg

60 Tablets

Rx only

INGREDIENTS AND APPEARANCE

SACUBITRIL AND VALSARTAN 
sacubitril and valsartan tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1921
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACUBITRIL (UNII: 17ERJ0MKGI) (SACUBITRILAT - UNII:SPI5PBF81S)	SACUBITRIL	24 mg
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	26 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1921-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
2	NDC: 70771-1921-8	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
3	NDC: 70771-1921-4	10 in 1 CARTON	07/08/2025
3	NDC: 70771-1921-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213719	07/08/2025

SACUBITRIL AND VALSARTAN 
sacubitril and valsartan tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1922
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACUBITRIL (UNII: 17ERJ0MKGI) (SACUBITRILAT - UNII:SPI5PBF81S)	SACUBITRIL	49 mg
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	51 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (dark-brown)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	72
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1922-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
2	NDC: 70771-1922-8	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
3	NDC: 70771-1922-4	10 in 1 CARTON	07/08/2025
3	NDC: 70771-1922-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213719	07/08/2025

SACUBITRIL AND VALSARTAN 
sacubitril and valsartan tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1923
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SACUBITRIL (UNII: 17ERJ0MKGI) (SACUBITRILAT - UNII:SPI5PBF81S)	SACUBITRIL	97 mg
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	103 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (light orange to orange)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	73
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1923-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
2	NDC: 70771-1923-8	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2025
3	NDC: 70771-1923-4	10 in 1 CARTON	07/08/2025
3	NDC: 70771-1923-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213719	07/08/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1921, 70771-1922, 70771-1923) , MANUFACTURE(70771-1921, 70771-1922, 70771-1923)