sacubitril and valsartan

Generic: sacubitril and valsartan

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sacubitril and valsartan
Generic Name sacubitril and valsartan
Labeler torrent pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sacubitril 97 mg/1, valsartan 103 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-636
Product ID 13668-636_d75a5a57-6ab2-4aa3-abc5-de648ac84e65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213604
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 13668636
Hyphenated Format 13668-636

Supplemental Identifiers

RxCUI
1656340 1656349 1656354
UPC
0313668635058 0313668634051 0313668636055
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 ANDA213604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 97 mg/1
  • 103 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (13668-636-05)
  • 180 TABLET in 1 BOTTLE (13668-636-33)
  • 60 TABLET in 1 BOTTLE (13668-636-60)
  • 100 BLISTER PACK in 1 CARTON (13668-636-74) / 10 TABLET in 1 BLISTER PACK (13668-636-71)
source: ndc

Packages (4)

13668-636-05 500 TABLET in 1 BOTTLE (13668-636-05) 13668-636-33 180 TABLET in 1 BOTTLE (13668-636-33) 13668-636-60 60 TABLET in 1 BOTTLE (13668-636-60) 13668-636-74 100 BLISTER PACK in 1 CARTON (13668-636-74) / 10 TABLET in 1 BLISTER PACK (13668-636-71)

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": "d75a5a57-6ab2-4aa3-abc5-de648ac84e65", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0313668635058", "0313668634051", "0313668636055"], "unii": ["80M03YXJ7I", "17ERJ0MKGI"], "rxcui": ["1656340", "1656349", "1656354"], "spl_set_id": ["59b7a07a-96ee-44b1-8dae-2b42169aa2c5"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (13668-636-05)", "package_ndc": "13668-636-05", "marketing_start_date": "20250716"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (13668-636-33)", "package_ndc": "13668-636-33", "marketing_start_date": "20250716"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (13668-636-60)", "package_ndc": "13668-636-60", "marketing_start_date": "20250716"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (13668-636-74)  / 10 TABLET in 1 BLISTER PACK (13668-636-71)", "package_ndc": "13668-636-74", "marketing_start_date": "20250716"}], "brand_name": "sacubitril and valsartan", "product_id": "13668-636_d75a5a57-6ab2-4aa3-abc5-de648ac84e65", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Neprilysin Inhibitor [EPC]", "Neprilysin Inhibitors [MoA]"], "product_ndc": "13668-636", "generic_name": "sacubitril and valsartan", "labeler_name": "Torrent 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": "ANDA213604", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}