amlodipine and atorvastatin

Generic: amlodipine and atorvastatin

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

Drug Facts

Product Profile

Brand Name amlodipine and atorvastatin
Generic Name amlodipine and atorvastatin
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, atorvastatin calcium trihydrate 10 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-762
Product ID 62332-762_d7b14922-f4b8-4e3e-afdd-056aee8dc35b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217279
Listing Expiration 2026-12-31
Marketing Start 2025-05-23

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs] hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332762
Hyphenated Format 62332-762

Supplemental Identifiers

RxCUI
404011 404013 597967 597971 597974 597977 597980 597984 597987 597990 597993
UPC
0362332765300 0362332758302 0362332764303 0362332759309 0362332762309 0362332761302 0362332763306 0362332760305 0362332757305 0362332755301 0362332756308
UNII
48A5M73Z4Q 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 amlodipine and atorvastatin (source: ndc)
Generic Name amlodipine and atorvastatin (source: ndc)
Application Number ANDA217279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62332-762-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62332-762-90)
source: ndc

Packages (2)

62332-762-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-762-30) 62332-762-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-762-90)

Ingredients (2)

amlodipine besylate (10 mg/1) atorvastatin calcium trihydrate (10 mg/1)

Linked Drug Pages (1)

Amlodipine and Atorvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7b14922-f4b8-4e3e-afdd-056aee8dc35b", "openfda": {"upc": ["0362332765300", "0362332758302", "0362332764303", "0362332759309", "0362332762309", "0362332761302", "0362332763306", "0362332760305", "0362332757305", "0362332755301", "0362332756308"], "unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597971", "597974", "597977", "597980", "597984", "597987", "597990", "597993"], "spl_set_id": ["1346631f-e6db-4c5c-a6af-5aa7b80a011d"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-762-30)", "package_ndc": "62332-762-30", "marketing_start_date": "20250523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-762-90)", "package_ndc": "62332-762-90", "marketing_start_date": "20250523"}], "brand_name": "Amlodipine and Atorvastatin", "product_id": "62332-762_d7b14922-f4b8-4e3e-afdd-056aee8dc35b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "62332-762", "generic_name": "Amlodipine and Atorvastatin", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Atorvastatin", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA217279", "marketing_category": "ANDA", "marketing_start_date": "20250523", "listing_expiration_date": "20261231"}