amlodipine and valsartan

Generic: amlodipine and valsartan

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine and valsartan
Generic Name amlodipine and valsartan
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine 5 mg/1, valsartan 160 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-214
Product ID 64380-214_1da81b6e-f1da-46de-8396-592cd855801b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090011
Listing Expiration 2026-12-31
Marketing Start 2022-10-24

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 64380214
Hyphenated Format 64380-214

Supplemental Identifiers

RxCUI
722126 722131 722134 722137
UPC
0364380216018 0364380215011 0364380214014 0364380217015
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 (64380-214-01)
  • 90 TABLET in 1 BOTTLE, PLASTIC (64380-214-02)
source: ndc

Packages (2)

64380-214-01 30 TABLET in 1 BOTTLE, PLASTIC (64380-214-01) 64380-214-02 90 TABLET in 1 BOTTLE, PLASTIC (64380-214-02)

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": "1da81b6e-f1da-46de-8396-592cd855801b", "openfda": {"nui": ["N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114", "N0000000070", "N0000175561"], "upc": ["0364380216018", "0364380215011", "0364380214014", "0364380217015"], "unii": ["1J444QC288", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["2094f801-4e92-47cd-9487-98f4043abd3c"], "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": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (64380-214-01)", "package_ndc": "64380-214-01", "marketing_start_date": "20221024"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (64380-214-02)", "package_ndc": "64380-214-02", "marketing_start_date": "20221024"}], "brand_name": "Amlodipine and Valsartan", "product_id": "64380-214_1da81b6e-f1da-46de-8396-592cd855801b", "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": "64380-214", "generic_name": "amlodipine and valsartan", "labeler_name": "Strides Pharma Science Limited", "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": "20221024", "listing_expiration_date": "20261231"}