amlodipine and valsartan

Generic: amlodipine and valsartan

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine and valsartan
Generic Name amlodipine and valsartan
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine 5 mg/1, valsartan 160 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-844
Product ID 23155-844_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090011
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc] calcium channel blocker [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
calcium channel antagonists [moa] cytochrome p450 3a inhibitors [moa] angiotensin 2 receptor antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155844
Hyphenated Format 23155-844

Supplemental Identifiers

RxCUI
722126 722131 722134 722137
UPC
0323155847093 0323155845099 0323155846096
UNII
1J444QC288 80M03YXJ7I
NUI
N0000000069 N0000175421 N0000175566 M0006414 N0000190114 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 amlodipine and valsartan (source: ndc)
Generic Name amlodipine and valsartan (source: ndc)
Application Number ANDA090011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03)
  • 90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09)
source: ndc

Packages (2)

23155-844-03 30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03) 23155-844-09 90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09)

Ingredients (2)

amlodipine (5 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

Amlodipine and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4", "openfda": {"nui": ["N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114", "N0000000070", "N0000175561"], "upc": ["0323155847093", "0323155845099", "0323155846096"], "unii": ["1J444QC288", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["55a1d22e-04ad-4475-9b05-0d534e289160"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (23155-844-03)", "package_ndc": "23155-844-03", "marketing_start_date": "20230315"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (23155-844-09)", "package_ndc": "23155-844-09", "marketing_start_date": "20230315"}], "brand_name": "Amlodipine and Valsartan", "product_id": "23155-844_a1e93c2f-051c-40b9-a0ba-bfcf78a9c2d4", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "23155-844", "generic_name": "amlodipine and valsartan", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Valsartan", "active_ingredients": [{"name": "AMLODIPINE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA090011", "marketing_category": "ANDA", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}