sacubitril and valsartan (72205-282)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler novadoz pharmaceuticals llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer

Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-282

Product ID 72205-282_84f16efa-73b8-419b-adb9-18c18c31a11f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213748

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 72205282

Hyphenated Format 72205-282

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0372205281189 0372205282605 0372205280601 0372205281608 0372205282186 0372205280182

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 ANDA213748 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

97 mg/1
103 mg/1

source: ndc

Packaging

180 TABLET, FILM COATED in 1 BOTTLE (72205-282-18)
60 TABLET, FILM COATED in 1 BOTTLE (72205-282-60)

source: ndc

Packages (2)

72205-282-18 180 TABLET, FILM COATED in 1 BOTTLE (72205-282-18) 72205-282-60 60 TABLET, FILM COATED in 1 BOTTLE (72205-282-60)

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": "84f16efa-73b8-419b-adb9-18c18c31a11f", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0372205281189", "0372205282605", "0372205280601", "0372205281608", "0372205282186", "0372205280182"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["44db8114-622e-41f6-96a1-447d47b0267c"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72205-282-18)", "package_ndc": "72205-282-18", "marketing_start_date": "20250722"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72205-282-60)", "package_ndc": "72205-282-60", "marketing_start_date": "20250722"}], "brand_name": "Sacubitril and Valsartan", "product_id": "72205-282_84f16efa-73b8-419b-adb9-18c18c31a11f", "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": "72205-282", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Novadoz Pharmaceuticals 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": "ANDA213748", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}