amlodipine and atorvastatin (46708-761)

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 5 mg/1, atorvastatin calcium trihydrate 80 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-761

Product ID 46708-761_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 46708761

Hyphenated Format 46708-761

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

5 mg/1
80 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (46708-761-30)
90 TABLET, FILM COATED in 1 BOTTLE (46708-761-90)

source: ndc

Packages (2)

46708-761-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-761-30) 46708-761-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-761-90)

Ingredients (2)

amlodipine besylate (5 mg/1) atorvastatin calcium trihydrate (80 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 (46708-761-30)", "package_ndc": "46708-761-30", "marketing_start_date": "20250523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-761-90)", "package_ndc": "46708-761-90", "marketing_start_date": "20250523"}], "brand_name": "Amlodipine and Atorvastatin", "product_id": "46708-761_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": "46708-761", "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": "5 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA217279", "marketing_category": "ANDA", "marketing_start_date": "20250523", "listing_expiration_date": "20261231"}