lovastatin

Generic: lovastatin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lovastatin
Generic Name lovastatin
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lovastatin 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-692
Product ID 43063-692_2fb37b45-9a7a-b6cd-e063-6294a90abe42
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 43063692
Hyphenated Format 43063-692

Supplemental Identifiers

RxCUI
197904
UPC
0343063692950
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
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-692-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-692-90)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95)
source: ndc

Packages (4)

43063-692-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-692-30) 43063-692-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-692-90) 43063-692-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93) 43063-692-95 1000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95)

Ingredients (1)

lovastatin (20 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": "2fb37b45-9a7a-b6cd-e063-6294a90abe42", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0343063692950"], "unii": ["9LHU78OQFD"], "rxcui": ["197904"], "spl_set_id": ["70e2bf86-4a78-4dfb-b6b1-8eb95f63684d"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-692-30)", "package_ndc": "43063-692-30", "marketing_start_date": "20230731"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-692-90)", "package_ndc": "43063-692-90", "marketing_start_date": "20160726"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93)", "package_ndc": "43063-692-93", "marketing_start_date": "20160726"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95)", "package_ndc": "43063-692-95", "marketing_start_date": "20221003"}], "brand_name": "Lovastatin", "product_id": "43063-692_2fb37b45-9a7a-b6cd-e063-6294a90abe42", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43063-692", "generic_name": "Lovastatin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA075991", "marketing_category": "ANDA", "marketing_start_date": "20021125", "listing_expiration_date": "20261231"}