amlodipine and valsartan

Generic: amlodipine and valsartan

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

Drug Facts

Product Profile

Brand Name amlodipine and valsartan
Generic Name amlodipine and valsartan
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, valsartan 160 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-458
Product ID 46708-458_3fb35d37-f05c-44ff-be96-076adaa6da32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202713
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

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 46708458
Hyphenated Format 46708-458

Supplemental Identifiers

RxCUI
722126 722131 722134 722137
UPC
0346708460303 0346708461300 0346708459307 0346708458300
UNII
864V2Q084H 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 amlodipine and valsartan (source: ndc)
Generic Name amlodipine and valsartan (source: ndc)
Application Number ANDA202713 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 CARTON (46708-458-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90)
source: ndc

Packages (5)

46708-458-10 100 TABLET, FILM COATED in 1 CARTON (46708-458-10) 46708-458-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30) 46708-458-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31) 46708-458-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71) 46708-458-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90)

Ingredients (2)

amlodipine besylate (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": "3fb35d37-f05c-44ff-be96-076adaa6da32", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0346708460303", "0346708461300", "0346708459307", "0346708458300"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["a9c442dc-749e-4de0-bca3-1044eb78da72"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (46708-458-10)", "package_ndc": "46708-458-10", "marketing_start_date": "20161201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30)", "package_ndc": "46708-458-30", "marketing_start_date": "20161201"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31)", "package_ndc": "46708-458-31", "marketing_start_date": "20161201"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71)", "package_ndc": "46708-458-71", "marketing_start_date": "20161201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90)", "package_ndc": "46708-458-90", "marketing_start_date": "20161201"}], "brand_name": "Amlodipine and Valsartan", "product_id": "46708-458_3fb35d37-f05c-44ff-be96-076adaa6da32", "dosage_form": "TABLET, FILM COATED", "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": "46708-458", "generic_name": "Amlodipine and Valsartan", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Valsartan", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA202713", "marketing_category": "ANDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}