lovastatin

Generic: lovastatin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lovastatin
Generic Name lovastatin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lovastatin 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-775
Product ID 71610-775_2db77596-4171-4597-ba55-045b97d142ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075991
Listing Expiration 2026-12-31
Marketing Start 2002-11-25

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 71610775
Hyphenated Format 71610-775

Supplemental Identifiers

RxCUI
197905
UNII
9LHU78OQFD
NUI
N0000175589 N0000000121

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 lovastatin (source: ndc)
Generic Name lovastatin (source: ndc)
Application Number ANDA075991 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-775-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-775-45)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-775-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-775-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80)
source: ndc

Packages (5)

71610-775-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-775-30) 71610-775-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-775-45) 71610-775-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-775-53) 71610-775-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-775-60) 71610-775-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80)

Ingredients (1)

lovastatin (40 mg/1)

Linked Drug Pages (1)

Lovastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2db77596-4171-4597-ba55-045b97d142ca", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["9LHU78OQFD"], "rxcui": ["197905"], "spl_set_id": ["0399c35c-513d-48e6-aa20-e8434e3b18d5"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-775-30)", "package_ndc": "71610-775-30", "marketing_start_date": "20240122"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-775-45)", "package_ndc": "71610-775-45", "marketing_start_date": "20240122"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-775-53)", "package_ndc": "71610-775-53", "marketing_start_date": "20240122"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-775-60)", "package_ndc": "71610-775-60", "marketing_start_date": "20240122"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80)", "package_ndc": "71610-775-80", "marketing_start_date": "20240122"}], "brand_name": "Lovastatin", "product_id": "71610-775_2db77596-4171-4597-ba55-045b97d142ca", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-775", "generic_name": "Lovastatin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA075991", "marketing_category": "ANDA", "marketing_start_date": "20021125", "listing_expiration_date": "20261231"}