amlodipine besylate and atorvastatin calcium

Generic: amlodipine besylate and atorvastatin calcium

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate and atorvastatin calcium
Generic Name amlodipine besylate and atorvastatin calcium
Labeler dr. reddy's laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-319
Product ID 43598-319_54058ac6-94e2-d2d3-5c46-886b3478fc76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203874
Listing Expiration 2026-12-31
Marketing Start 2014-03-17

Pharmacologic Class

Classes
calcium channel antagonists [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 43598319
Hyphenated Format 43598-319

Supplemental Identifiers

RxCUI
404011 404013 597967 597971 597974 597977 597980 597984 597987 597990 597993
UPC
0343598323305 0343598315300 0343598320304 0343598317304 0343598313306 0343598322308 0343598319308 0343598316307 0343598314303
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 besylate and atorvastatin calcium (source: ndc)
Generic Name amlodipine besylate and atorvastatin calcium (source: ndc)
Application Number ANDA203874 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-319-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-319-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (43598-319-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43598-319-90)
source: ndc

Packages (4)

43598-319-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-319-05) 43598-319-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-319-30) 43598-319-60 60 TABLET, FILM COATED in 1 BOTTLE (43598-319-60) 43598-319-90 90 TABLET, FILM COATED in 1 BOTTLE (43598-319-90)

Ingredients (2)

amlodipine besylate (5 mg/1) atorvastatin calcium trihydrate (20 mg/1)

Linked Drug Pages (1)

Amlodipine besylate and Atorvastatin calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "54058ac6-94e2-d2d3-5c46-886b3478fc76", "openfda": {"upc": ["0343598323305", "0343598315300", "0343598320304", "0343598317304", "0343598313306", "0343598322308", "0343598319308", "0343598316307", "0343598314303"], "unii": ["48A5M73Z4Q", "864V2Q084H"], "rxcui": ["404011", "404013", "597967", "597971", "597974", "597977", "597980", "597984", "597987", "597990", "597993"], "spl_set_id": ["abee4a34-89cc-d886-192c-32582ab8f024"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-319-05)", "package_ndc": "43598-319-05", "marketing_start_date": "20140317"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-319-30)", "package_ndc": "43598-319-30", "marketing_start_date": "20140317"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (43598-319-60)", "package_ndc": "43598-319-60", "marketing_start_date": "20140317"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43598-319-90)", "package_ndc": "43598-319-90", "marketing_start_date": "20140317"}], "brand_name": "Amlodipine besylate and Atorvastatin calcium", "product_id": "43598-319_54058ac6-94e2-d2d3-5c46-886b3478fc76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43598-319", "generic_name": "Amlodipine besylate and Atorvastatin calcium", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine besylate and Atorvastatin calcium", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA203874", "marketing_category": "ANDA", "marketing_start_date": "20140317", "listing_expiration_date": "20261231"}