caduet

Generic: amlodipine and atorvastatin

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name caduet
Generic Name amlodipine and atorvastatin
Labeler pfizer laboratories div pfizer inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-6565
Product ID 0069-6565_1ce17020-050b-4fdc-8201-1a5648ca8a66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021540
Listing Expiration 2026-12-31
Marketing Start 2022-08-31

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 00696565
Hyphenated Format 0069-6565

Supplemental Identifiers

RxCUI
404011 404013 597967 597977 597980 597984 597987 597990 750199 750203 750207 750211 750227 750231 750235 750239
UPC
0300692150305 0300692250302 0300692170303 0300692160304 0300692190301 0300696565303 0300696747303 0300697810303 0300692270300 0300697232303 0300697476301 0300696180308 0300696323309 0300692260301 0300697654303
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 caduet (source: ndc)
Generic Name amlodipine and atorvastatin (source: ndc)
Application Number NDA021540 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0069-6565-30)
source: ndc

Packages (1)

0069-6565-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-6565-30)

Ingredients (2)

amlodipine besylate (5 mg/1) atorvastatin calcium trihydrate (40 mg/1)

Linked Drug Pages (1)

Caduet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ce17020-050b-4fdc-8201-1a5648ca8a66", "openfda": {"upc": ["0300692150305", "0300692250302", "0300692170303", "0300692160304", "0300692190301", "0300696565303", "0300696747303", "0300697810303", "0300692270300", "0300697232303", "0300697476301", "0300696180308", "0300696323309", "0300692260301", "0300697654303"], "unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597977", "597980", "597984", "597987", "597990", "750199", "750203", "750207", "750211", "750227", "750231", "750235", "750239"], "spl_set_id": ["6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0069-6565-30)", "package_ndc": "0069-6565-30", "marketing_start_date": "20220831"}], "brand_name": "Caduet", "product_id": "0069-6565_1ce17020-050b-4fdc-8201-1a5648ca8a66", "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": "0069-6565", "generic_name": "amlodipine and atorvastatin", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Caduet", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "NDA021540", "marketing_category": "NDA", "marketing_start_date": "20220831", "listing_expiration_date": "20261231"}