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 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-548
Product ID 43063-548_2f3a8f82-8530-3a64-e063-6294a90aa0b0
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 43063548
Hyphenated Format 43063-548

Supplemental Identifiers

RxCUI
197905
UPC
0343063548905
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
  • 14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95)
source: ndc

Packages (5)

43063-548-14 14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14) 43063-548-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30) 43063-548-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90) 43063-548-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93) 43063-548-95 1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95)

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": "2f3a8f82-8530-3a64-e063-6294a90aa0b0", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0343063548905"], "unii": ["9LHU78OQFD"], "rxcui": ["197905"], "spl_set_id": ["eea93a4b-f804-4b9c-aabf-e906f03c1e80"], "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": "14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14)", "package_ndc": "43063-548-14", "marketing_start_date": "20141115"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30)", "package_ndc": "43063-548-30", "marketing_start_date": "20141115"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90)", "package_ndc": "43063-548-90", "marketing_start_date": "20141115"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93)", "package_ndc": "43063-548-93", "marketing_start_date": "20141224"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95)", "package_ndc": "43063-548-95", "marketing_start_date": "20220916"}], "brand_name": "Lovastatin", "product_id": "43063-548_2f3a8f82-8530-3a64-e063-6294a90aa0b0", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43063-548", "generic_name": "Lovastatin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}