simvastatin

Generic: simvastatin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 80 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-054
Product ID 65862-054_7aa9abed-6d40-4370-aeac-4d34e2cf0416
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077691
Listing Expiration 2026-12-31
Marketing Start 2006-12-20

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862054
Hyphenated Format 65862-054

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UNII
AGG2FN16EV
NUI
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 simvastatin (source: ndc)
Generic Name simvastatin (source: ndc)
Application Number ANDA077691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-054-30)
  • 3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39)
  • 45 TABLET, FILM COATED in 1 BOTTLE (65862-054-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-054-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-054-99)
source: ndc

Packages (6)

65862-054-00 100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00) 65862-054-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-054-30) 65862-054-39 3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39) 65862-054-45 45 TABLET, FILM COATED in 1 BOTTLE (65862-054-45) 65862-054-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-054-90) 65862-054-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-054-99)

Ingredients (1)

simvastatin (80 mg/1)

Linked Drug Pages (1)

Simvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7aa9abed-6d40-4370-aeac-4d34e2cf0416", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["4724dbb4-3613-4e6a-948f-a43d34f97f06"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00)", "package_ndc": "65862-054-00", "marketing_start_date": "20061220"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-054-30)", "package_ndc": "65862-054-30", "marketing_start_date": "20061220"}, {"sample": false, "description": "3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39)", "package_ndc": "65862-054-39", "marketing_start_date": "20061220"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (65862-054-45)", "package_ndc": "65862-054-45", "marketing_start_date": "20061220"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-054-90)", "package_ndc": "65862-054-90", "marketing_start_date": "20061220"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-054-99)", "package_ndc": "65862-054-99", "marketing_start_date": "20061220"}], "brand_name": "Simvastatin", "product_id": "65862-054_7aa9abed-6d40-4370-aeac-4d34e2cf0416", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "65862-054", "generic_name": "Simvastatin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA077691", "marketing_category": "ANDA", "marketing_start_date": "20061220", "listing_expiration_date": "20261231"}