lovastatin

Generic: lovastatin

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lovastatin
Generic Name lovastatin
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lovastatin 40 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-316
Product ID 68001-316_26682060-6c21-5cd7-e063-6394a90ab4dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078296
Listing Expiration 2026-12-31
Marketing Start 2007-11-01

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 68001316
Hyphenated Format 68001-316

Supplemental Identifiers

RxCUI
197903 197904 197905
UPC
0368001316002 0368001314008 0368001315005
UNII
9LHU78OQFD
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 lovastatin (source: ndc)
Generic Name lovastatin (source: ndc)
Application Number ANDA078296 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68001-316-00)
  • 1000 TABLET in 1 BOTTLE (68001-316-08)
source: ndc

Packages (2)

68001-316-00 100 TABLET in 1 BOTTLE (68001-316-00) 68001-316-08 1000 TABLET in 1 BOTTLE (68001-316-08)

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": "26682060-6c21-5cd7-e063-6394a90ab4dd", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0368001316002", "0368001314008", "0368001315005"], "unii": ["9LHU78OQFD"], "rxcui": ["197903", "197904", "197905"], "spl_set_id": ["7b86160d-74a9-4774-b5b3-5641e686991f"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68001-316-00)", "package_ndc": "68001-316-00", "marketing_start_date": "20170207"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68001-316-08)", "package_ndc": "68001-316-08", "marketing_start_date": "20170207"}], "brand_name": "Lovastatin", "product_id": "68001-316_26682060-6c21-5cd7-e063-6394a90ab4dd", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68001-316", "generic_name": "lovastatin", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA078296", "marketing_category": "ANDA", "marketing_start_date": "20071101", "listing_expiration_date": "20261231"}