sacubitril and valsartan (73190-007)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler avkare

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 73190-007

Product ID 73190-007_4c260039-9848-e878-e063-6294a90a3dcb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213748

Listing Expiration 2027-12-31

Marketing Start 2025-01-21

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 73190007

Hyphenated Format 73190-007

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0373190002186 0373190001189 0373190002605 0373190003602 0373190001608 0373190003183

UNII

80M03YXJ7I 17ERJ0MKGI

NUI

N0000000070 N0000175561

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 ANDA213748 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

97 mg/1
103 mg/1

source: ndc

Packaging

1000 TABLET, FILM COATED in 1 BOTTLE (73190-007-10)
180 TABLET, FILM COATED in 1 BOTTLE (73190-007-18)
60 TABLET, FILM COATED in 1 BOTTLE (73190-007-60)

source: ndc

Packages (3)

73190-007-10 1000 TABLET, FILM COATED in 1 BOTTLE (73190-007-10) 73190-007-18 180 TABLET, FILM COATED in 1 BOTTLE (73190-007-18) 73190-007-60 60 TABLET, FILM COATED in 1 BOTTLE (73190-007-60)

Ingredients (2)

sacubitril (97 mg/1) valsartan (103 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": "4c260039-9848-e878-e063-6294a90a3dcb", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0373190002186", "0373190001189", "0373190002605", "0373190003602", "0373190001608", "0373190003183"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["2c39c326-34a2-b7f4-e063-6294a90a6732"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (73190-007-10)", "package_ndc": "73190-007-10", "marketing_start_date": "20260225"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (73190-007-18)", "package_ndc": "73190-007-18", "marketing_start_date": "20250121"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (73190-007-60)", "package_ndc": "73190-007-60", "marketing_start_date": "20250121"}], "brand_name": "Sacubitril and Valsartan", "product_id": "73190-007_4c260039-9848-e878-e063-6294a90a3dcb", "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": "73190-007", "generic_name": "Sacubitril and Valsartan", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sacubitril and Valsartan", "active_ingredients": [{"name": "SACUBITRIL", "strength": "97 mg/1"}, {"name": "VALSARTAN", "strength": "103 mg/1"}], "application_number": "ANDA213748", "marketing_category": "ANDA", "marketing_start_date": "20250121", "listing_expiration_date": "20271231"}