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 71610-709
Product ID 71610-709_20d6175b-0f94-4133-8b95-b8e3a4ef4139
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075551
Listing Expiration 2026-12-31
Marketing Start 2001-12-17

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 71610709
Hyphenated Format 71610-709

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 ANDA075551 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE (71610-709-45)
source: ndc

Packages (1)

71610-709-45 45 TABLET in 1 BOTTLE (71610-709-45)

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": "20d6175b-0f94-4133-8b95-b8e3a4ef4139", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["9LHU78OQFD"], "rxcui": ["197905"], "spl_set_id": ["7e96b174-3887-4908-9b9f-5ef93540f96a"], "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": "45 TABLET in 1 BOTTLE (71610-709-45)", "package_ndc": "71610-709-45", "marketing_start_date": "20230531"}], "brand_name": "Lovastatin", "product_id": "71610-709_20d6175b-0f94-4133-8b95-b8e3a4ef4139", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-709", "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": "ANDA075551", "marketing_category": "ANDA", "marketing_start_date": "20011217", "listing_expiration_date": "20261231"}