amlodipine and atorvastatin (0378-4514)

Drug Facts

Product Profile

Brand Name amlodipine and atorvastatin

Generic Name amlodipine and atorvastatin

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 5 mg/1, atorvastatin calcium trihydrate 20 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4514

Product ID 0378-4514_bee991e8-1686-425f-95cb-ff8d3133fffa

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200465

Listing Expiration 2026-12-31

Marketing Start 2014-05-21

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 03784514

Hyphenated Format 0378-4514

Supplemental Identifiers

RxCUI

404011 404013 597967 597977 597980 597984 597987 597990

UPC

0303784519936 0303784514931 0303784520932 0303784516935 0303784517932 0303784515938 0303784518939 0303784513934

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 ANDA200465 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
20 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4514-93)

source: ndc

Packages (1)

0378-4514-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4514-93)

Ingredients (2)

amlodipine besylate (5 mg/1) atorvastatin calcium trihydrate (20 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": "bee991e8-1686-425f-95cb-ff8d3133fffa", "openfda": {"upc": ["0303784519936", "0303784514931", "0303784520932", "0303784516935", "0303784517932", "0303784515938", "0303784518939", "0303784513934"], "unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597977", "597980", "597984", "597987", "597990"], "spl_set_id": ["4be76756-4114-4d50-a36c-fd410f6c773d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4514-93)", "package_ndc": "0378-4514-93", "marketing_start_date": "20140521"}], "brand_name": "Amlodipine and atorvastatin", "product_id": "0378-4514_bee991e8-1686-425f-95cb-ff8d3133fffa", "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": "0378-4514", "generic_name": "Amlodipine and atorvastatin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and atorvastatin", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA200465", "marketing_category": "ANDA", "marketing_start_date": "20140521", "listing_expiration_date": "20261231"}