sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler laurus labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-931
Product ID 42385-931_b47b5c7e-1c20-429c-9560-07f5f06cdce3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213676
Listing Expiration 2026-12-31
Marketing Start 2024-11-11

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385931
Hyphenated Format 42385-931

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UPC
0342385932102 0342385932300 0342385930306 0342385931303
UNII
80M03YXJ7I 17ERJ0MKGI
NUI
N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sacubitril and valsartan (source: ndc)
Generic Name sacubitril and valsartan (source: ndc)
Application Number ANDA213676 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 49 mg/1
  • 51 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (42385-931-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-931-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (42385-931-60)
  • 100 BLISTER PACK in 1 CARTON (42385-931-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-10)
  • 100 BLISTER PACK in 1 CARTON (42385-931-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17)
source: ndc

Packages (5)

42385-931-18 180 TABLET, FILM COATED in 1 BOTTLE (42385-931-18) 42385-931-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-931-30) 42385-931-60 60 TABLET, FILM COATED in 1 BOTTLE (42385-931-60) 42385-931-68 100 BLISTER PACK in 1 CARTON (42385-931-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-10) 42385-931-72 100 BLISTER PACK in 1 CARTON (42385-931-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17)

Ingredients (2)

sacubitril (49 mg/1) valsartan (51 mg/1)

Linked Drug Pages (1)

Sacubitril and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b47b5c7e-1c20-429c-9560-07f5f06cdce3", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0342385932102", "0342385932300", "0342385930306", "0342385931303"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["b47b5c7e-1c20-429c-9560-07f5f06cdce3"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (42385-931-18)", "package_ndc": "42385-931-18", "marketing_start_date": "20241111"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42385-931-30)", "package_ndc": "42385-931-30", "marketing_start_date": "20241111"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42385-931-60)", "package_ndc": "42385-931-60", "marketing_start_date": "20241111"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42385-931-68)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-10)", "package_ndc": "42385-931-68", "marketing_start_date": "20241111"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42385-931-72)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-931-17)", "package_ndc": "42385-931-72", "marketing_start_date": "20241111"}], "brand_name": "Sacubitril and Valsartan", "product_id": "42385-931_b47b5c7e-1c20-429c-9560-07f5f06cdce3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "42385-931", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "49 mg/1"}, {"name": "VALSARTAN", "strength": "51 mg/1"}], "application_number": "ANDA213676", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20261231"}