amlodipine and atorvastatin (46708-757)

Drug Facts

Product Profile

Brand Name amlodipine and atorvastatin

Generic Name amlodipine and atorvastatin

Labeler alembic pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 2.5 mg/1, atorvastatin calcium trihydrate 40 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-757

Product ID 46708-757_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c

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 46708757

Hyphenated Format 46708-757

Supplemental Identifiers

RxCUI

404011 404013 597967 597971 597974 597977 597980 597984 597987 597990 597993

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

2.5 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (46708-757-30)
90 TABLET, FILM COATED in 1 BOTTLE (46708-757-90)

source: ndc

Packages (2)

46708-757-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-757-30) 46708-757-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-757-90)

Ingredients (2)

amlodipine besylate (2.5 mg/1) atorvastatin calcium trihydrate (40 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": "ecab983e-6ed8-4440-b7b4-7ac4bf39b26c", "openfda": {"unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597971", "597974", "597977", "597980", "597984", "597987", "597990", "597993"], "spl_set_id": ["ecab983e-6ed8-4440-b7b4-7ac4bf39b26c"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-757-30)", "package_ndc": "46708-757-30", "marketing_start_date": "20250523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-757-90)", "package_ndc": "46708-757-90", "marketing_start_date": "20250523"}], "brand_name": "Amlodipine and Atorvastatin", "product_id": "46708-757_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c", "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": "46708-757", "generic_name": "Amlodipine and Atorvastatin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Atorvastatin", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA217279", "marketing_category": "ANDA", "marketing_start_date": "20250523", "listing_expiration_date": "20261231"}