lovastatin

Generic: lovastatin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lovastatin
Generic Name lovastatin
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lovastatin 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1191
Product ID 63629-1191_4418be45-ac95-468d-8603-53d72198b4b7
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 636291191
Hyphenated Format 63629-1191

Supplemental Identifiers

RxCUI
197903
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
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (63629-1191-1)
source: ndc

Packages (1)

63629-1191-1 1000 TABLET in 1 BOTTLE (63629-1191-1)

Ingredients (1)

lovastatin (10 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": "4418be45-ac95-468d-8603-53d72198b4b7", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["9LHU78OQFD"], "rxcui": ["197903"], "spl_set_id": ["a623c1da-e94e-41be-900c-9e74376d36c8"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (63629-1191-1)", "package_ndc": "63629-1191-1", "marketing_start_date": "20021125"}], "brand_name": "Lovastatin", "product_id": "63629-1191_4418be45-ac95-468d-8603-53d72198b4b7", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "63629-1191", "generic_name": "Lovastatin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA075991", "marketing_category": "ANDA", "marketing_start_date": "20021125", "listing_expiration_date": "20261231"}