valsartan

Generic: valsartan

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan
Generic Name valsartan
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

valsartan 4 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-310
Product ID 70954-310_12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214102
Listing Expiration 2026-12-31
Marketing Start 2021-11-02

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 70954310
Hyphenated Format 70954-310

Supplemental Identifiers

RxCUI
1996254
UPC
0370954310105 0370954310204
UNII
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 valsartan (source: ndc)
Generic Name valsartan (source: ndc)
Application Number ANDA214102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (70954-310-10)
  • 473 mL in 1 BOTTLE, PLASTIC (70954-310-20)
source: ndc

Packages (2)

70954-310-10 120 mL in 1 BOTTLE, PLASTIC (70954-310-10) 70954-310-20 473 mL in 1 BOTTLE, PLASTIC (70954-310-20)

Ingredients (1)

valsartan (4 mg/mL)

Linked Drug Pages (1)

Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0370954310105", "0370954310204"], "unii": ["80M03YXJ7I"], "rxcui": ["1996254"], "spl_set_id": ["959b6790-feb7-45a9-9ea4-0ee1a7fce048"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (70954-310-10)", "package_ndc": "70954-310-10", "marketing_start_date": "20211102"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (70954-310-20)", "package_ndc": "70954-310-20", "marketing_start_date": "20211102"}], "brand_name": "Valsartan", "product_id": "70954-310_12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c", "dosage_form": "SOLUTION", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "70954-310", "generic_name": "Valsartan", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan", "active_ingredients": [{"name": "VALSARTAN", "strength": "4 mg/mL"}], "application_number": "ANDA214102", "marketing_category": "ANDA", "marketing_start_date": "20211102", "listing_expiration_date": "20261231"}