sacubitril and valsartan sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sacubitril 49 mg/1, valsartan 51 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-644
Product ID 43598-644_2745b697-4155-c757-7e40-826bf72e469d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213627
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

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 43598644
Hyphenated Format 43598-644

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
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 sacubitril and valsartan (source: ndc)
Generic Name sacubitril and valsartan (source: ndc)
Application Number ANDA213627 (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 (43598-644-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (43598-644-60)
source: ndc

Packages (2)

43598-644-18 180 TABLET, FILM COATED in 1 BOTTLE (43598-644-18) 43598-644-60 60 TABLET, FILM COATED in 1 BOTTLE (43598-644-60)

Ingredients (2)

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

Linked Drug Pages (1)

Sacubitril and Valsartan Sacubitril and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2745b697-4155-c757-7e40-826bf72e469d", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["f4789255-b59b-544b-bbbe-2edd07da6079"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (43598-644-18)", "package_ndc": "43598-644-18", "marketing_start_date": "20250716"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (43598-644-60)", "package_ndc": "43598-644-60", "marketing_start_date": "20250716"}], "brand_name": "Sacubitril and Valsartan Sacubitril and Valsartan", "product_id": "43598-644_2745b697-4155-c757-7e40-826bf72e469d", "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": "43598-644", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "brand_name_suffix": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "49 mg/1"}, {"name": "VALSARTAN", "strength": "51 mg/1"}], "application_number": "ANDA213627", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}