ezetimibe and simvastatin

Generic: ezetimibe and simvastatin

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin
Generic Name ezetimibe and simvastatin
Labeler dr.reddys laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1, simvastatin 80 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-745
Product ID 43598-745_697ae8a7-2359-455f-9c21-e266f1c31288
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200909
Marketing Start 2018-11-20
Marketing End 2026-11-30

Pharmacologic Class

Established (EPC)
dietary cholesterol absorption inhibitor [epc] hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]
Physiologic Effect
decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598745
Hyphenated Format 43598-745

Supplemental Identifiers

RxCUI
476345 476349 476350 476351
UPC
0343598745909 0343598742908 0343598743905 0343598744902
UNII
EOR26LQQ24 AGG2FN16EV
NUI
N0000008553 N0000175911 N0000175589 N0000000121

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 ezetimibe and simvastatin (source: ndc)
Generic Name ezetimibe and simvastatin (source: ndc)
Application Number ANDA200909 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (43598-745-05)
  • 30 TABLET in 1 BOTTLE (43598-745-30)
  • 90 TABLET in 1 BOTTLE (43598-745-90)
source: ndc

Packages (3)

43598-745-05 500 TABLET in 1 BOTTLE (43598-745-05) 43598-745-30 30 TABLET in 1 BOTTLE (43598-745-30) 43598-745-90 90 TABLET in 1 BOTTLE (43598-745-90)

Ingredients (2)

ezetimibe (10 mg/1) simvastatin (80 mg/1)

Linked Drug Pages (1)

Ezetimibe and Simvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "697ae8a7-2359-455f-9c21-e266f1c31288", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "upc": ["0343598745909", "0343598742908", "0343598743905", "0343598744902"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["023ca87a-1b04-8c17-dc4f-e2758b0771e2"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43598-745-05)", "package_ndc": "43598-745-05", "marketing_end_date": "20261130", "marketing_start_date": "20181120"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43598-745-30)", "package_ndc": "43598-745-30", "marketing_end_date": "20261130", "marketing_start_date": "20181120"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43598-745-90)", "package_ndc": "43598-745-90", "marketing_end_date": "20261130", "marketing_start_date": "20181120"}], "brand_name": "Ezetimibe and Simvastatin", "product_id": "43598-745_697ae8a7-2359-455f-9c21-e266f1c31288", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43598-745", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe and Simvastatin", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA200909", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20181120"}