norvasc

Generic: amlodipine besylate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name norvasc
Generic Name amlodipine besylate
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-354
Product ID 58151-354_643fa1a0-53d9-4ce8-bc04-44285b006997
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019787
Listing Expiration 2026-12-31
Marketing Start 2024-09-24

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151354
Hyphenated Format 58151-354

Supplemental Identifiers

RxCUI
197361 212542 212549 212575 308135 308136
UPC
0358151354771
UNII
864V2Q084H

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 norvasc (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number NDA019787 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 300 TABLET in 1 BOTTLE (58151-354-30)
  • 90 TABLET in 1 BOTTLE (58151-354-77)
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-354-88) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

58151-354-30 300 TABLET in 1 BOTTLE (58151-354-30) 58151-354-77 90 TABLET in 1 BOTTLE (58151-354-77) 58151-354-88 100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-354-88) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

Norvasc ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "643fa1a0-53d9-4ce8-bc04-44285b006997", "openfda": {"upc": ["0358151354771"], "unii": ["864V2Q084H"], "rxcui": ["197361", "212542", "212549", "212575", "308135", "308136"], "spl_set_id": ["7367289c-b0b0-466a-83e2-558e2985c29f"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE (58151-354-30)", "package_ndc": "58151-354-30", "marketing_start_date": "20250123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (58151-354-77)", "package_ndc": "58151-354-77", "marketing_start_date": "20241231"}, {"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-354-88)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "58151-354-88", "marketing_start_date": "20240924"}], "brand_name": "Norvasc", "product_id": "58151-354_643fa1a0-53d9-4ce8-bc04-44285b006997", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "58151-354", "generic_name": "amlodipine besylate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norvasc", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "NDA019787", "marketing_category": "NDA", "marketing_start_date": "20240924", "listing_expiration_date": "20261231"}