exforge

Generic: amlodipine besylate and valsartan

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name exforge
Generic Name amlodipine besylate and valsartan
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0488
Product ID 0078-0488_7e675018-c404-4ea5-ac95-a18d7cb78301
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021990
Listing Expiration 2027-12-31
Marketing Start 2007-06-20

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 00780488
Hyphenated Format 0078-0488

Supplemental Identifiers

RxCUI
722126 722131 722134 722137 724879 724887 724891 724895
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 exforge (source: ndc)
Generic Name amlodipine besylate and valsartan (source: ndc)
Application Number NDA021990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)
source: ndc

Packages (1)

0078-0488-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)

Ingredients (2)

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

Linked Drug Pages (1)

Exforge ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e675018-c404-4ea5-ac95-a18d7cb78301", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137", "724879", "724887", "724891", "724895"], "spl_set_id": ["d0caec89-96ec-411d-a933-63eda74a6da7"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)", "package_ndc": "0078-0488-15", "marketing_start_date": "20070620"}], "brand_name": "Exforge", "product_id": "0078-0488_7e675018-c404-4ea5-ac95-a18d7cb78301", "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": "0078-0488", "generic_name": "amlodipine besylate and valsartan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exforge", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "NDA021990", "marketing_category": "NDA", "marketing_start_date": "20070620", "listing_expiration_date": "20271231"}