lovastatin

Generic: lovastatin

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lovastatin 20 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8326
Product ID 68788-8326_737d8aeb-f192-4b4f-af2a-6a22d4fe6ba1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078296
Listing Expiration 2026-12-31
Marketing Start 2023-01-19

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 687888326
Hyphenated Format 68788-8326

Supplemental Identifiers

RxCUI
197904
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 ANDA078296 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8326-1)
  • 30 TABLET in 1 BOTTLE (68788-8326-3)
  • 60 TABLET in 1 BOTTLE (68788-8326-6)
  • 90 TABLET in 1 BOTTLE (68788-8326-9)
source: ndc

Packages (4)

68788-8326-1 100 TABLET in 1 BOTTLE (68788-8326-1) 68788-8326-3 30 TABLET in 1 BOTTLE (68788-8326-3) 68788-8326-6 60 TABLET in 1 BOTTLE (68788-8326-6) 68788-8326-9 90 TABLET in 1 BOTTLE (68788-8326-9)

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": "737d8aeb-f192-4b4f-af2a-6a22d4fe6ba1", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["9LHU78OQFD"], "rxcui": ["197904"], "spl_set_id": ["22c9f2d8-7bcd-4415-bbc8-505720033966"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8326-1)", "package_ndc": "68788-8326-1", "marketing_start_date": "20230119"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8326-3)", "package_ndc": "68788-8326-3", "marketing_start_date": "20230119"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8326-6)", "package_ndc": "68788-8326-6", "marketing_start_date": "20230119"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8326-9)", "package_ndc": "68788-8326-9", "marketing_start_date": "20230119"}], "brand_name": "Lovastatin", "product_id": "68788-8326_737d8aeb-f192-4b4f-af2a-6a22d4fe6ba1", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8326", "generic_name": "lovastatin", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078296", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20261231"}