amlodipine and atorvastatin

Generic: amlodipine and atorvastatin

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine and atorvastatin
Generic Name amlodipine and atorvastatin
Labeler prasco laboratories
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-268
Product ID 66993-268_54ec553c-f76b-4d59-bc4e-fc519300a705
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021540
Listing Expiration 2026-12-31
Marketing Start 2022-03-14

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 66993268
Hyphenated Format 66993-268

Supplemental Identifiers

RxCUI
404011 404013 597967 597971 597974 597977 597980 597984 597987 597990 597993
UPC
0366993265308 0366993267302 0366993264301 0366993268309 0366993263304 0366993273303 0366993272306 0366993271309 0366993266305 0366993269306 0366993270302
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 NDA021540 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (66993-268-30)
source: ndc

Packages (1)

66993-268-30 30 TABLET, COATED in 1 BOTTLE (66993-268-30)

Ingredients (2)

amlodipine besylate (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": "54ec553c-f76b-4d59-bc4e-fc519300a705", "openfda": {"upc": ["0366993265308", "0366993267302", "0366993264301", "0366993268309", "0366993263304", "0366993273303", "0366993272306", "0366993271309", "0366993266305", "0366993269306", "0366993270302"], "unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597971", "597974", "597977", "597980", "597984", "597987", "597990", "597993"], "spl_set_id": ["14124e56-77ba-426d-8f5a-dbe42eda1a20"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (66993-268-30)", "package_ndc": "66993-268-30", "marketing_start_date": "20220314"}], "brand_name": "Amlodipine and Atorvastatin", "product_id": "66993-268_54ec553c-f76b-4d59-bc4e-fc519300a705", "dosage_form": "TABLET, 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": "66993-268", "generic_name": "Amlodipine and Atorvastatin", "labeler_name": "Prasco Laboratories", "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": "40 mg/1"}], "application_number": "NDA021540", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220314", "listing_expiration_date": "20261231"}