sacubitril and valsartan (33342-572)

Drug Facts

Product Profile

Brand Name sacubitril and valsartan

Generic Name sacubitril and valsartan

Labeler macleods pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-572

Product ID 33342-572_103c39e2-f3c8-40fc-a57e-3af018fb4af4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA213728

Listing Expiration 2026-12-31

Marketing Start 2024-10-16

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 33342572

Hyphenated Format 33342-572

Supplemental Identifiers

RxCUI

1656340 1656349 1656354

UPC

0333342570574 0333342570093 0333342571571 0333342571090 0333342572097

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 ANDA213728 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

97 mg/1
103 mg/1

source: ndc

Packaging

60 TABLET in 1 BOTTLE (33342-572-09)
180 TABLET in 1 BOTTLE (33342-572-57)

source: ndc

Packages (2)

33342-572-09 60 TABLET in 1 BOTTLE (33342-572-09) 33342-572-57 180 TABLET in 1 BOTTLE (33342-572-57)

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": "103c39e2-f3c8-40fc-a57e-3af018fb4af4", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0333342570574", "0333342570093", "0333342571571", "0333342571090", "0333342572097"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["103c39e2-f3c8-40fc-a57e-3af018fb4af4"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (33342-572-09)", "package_ndc": "33342-572-09", "marketing_start_date": "20241016"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (33342-572-57)", "package_ndc": "33342-572-57", "marketing_start_date": "20241016"}], "brand_name": "Sacubitril and Valsartan", "product_id": "33342-572_103c39e2-f3c8-40fc-a57e-3af018fb4af4", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "33342-572", "generic_name": "Sacubitril and Valsartan", "labeler_name": "Macleods Pharmaceuticals Limited", "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": "ANDA213728", "marketing_category": "ANDA", "marketing_start_date": "20241016", "listing_expiration_date": "20261231"}