sacubitril and valsartan (82293-040)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler novugen pharma (usa) llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer

Novugen Pharma (USA) LLC

Identifiers & Regulatory

Product NDC 82293-040

Product ID 82293-040_3a2bdb2c-344b-6f93-e063-6294a90a41ef

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213611

Marketing Start 2025-07-16

Marketing End 2027-04-30

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 82293040

Hyphenated Format 82293-040

Supplemental Identifiers

RxCUI

1656354

UPC

0382293040100 0382293040209

UNII

17ERJ0MKGI 80M03YXJ7I

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 ANDA213611 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

97 mg/1
103 mg/1

source: ndc

Packaging

60 TABLET, FILM COATED in 1 BOTTLE (82293-040-10)
180 TABLET, FILM COATED in 1 BOTTLE (82293-040-20)
100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-040-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-040-31)

source: ndc

Packages (3)

82293-040-10 60 TABLET, FILM COATED in 1 BOTTLE (82293-040-10) 82293-040-20 180 TABLET, FILM COATED in 1 BOTTLE (82293-040-20) 82293-040-30 100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-040-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-040-31)

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": "3a2bdb2c-344b-6f93-e063-6294a90a41ef", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0382293040100", "0382293040209"], "unii": ["17ERJ0MKGI", "80M03YXJ7I"], "rxcui": ["1656354"], "spl_set_id": ["ec37696b-eaac-4c74-9328-94857ce998e5"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novugen Pharma (USA) LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82293-040-10)", "package_ndc": "82293-040-10", "marketing_end_date": "20270430", "marketing_start_date": "20250716"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (82293-040-20)", "package_ndc": "82293-040-20", "marketing_end_date": "20270430", "marketing_start_date": "20250716"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (82293-040-30)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (82293-040-31)", "package_ndc": "82293-040-30", "marketing_end_date": "20270430", "marketing_start_date": "20250716"}], "brand_name": "Sacubitril and Valsartan", "product_id": "82293-040_3a2bdb2c-344b-6f93-e063-6294a90a41ef", "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": "82293-040", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Novugen Pharma (USA) LLC", "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": "ANDA213611", "marketing_category": "ANDA", "marketing_end_date": "20270430", "marketing_start_date": "20250716"}