lovastatin

Generic: lovastatin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lovastatin
Generic Name lovastatin
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lovastatin 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3064
Product ID 70518-3064_3a0da39c-0adf-1571-e063-6294a90ac9be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075551
Listing Expiration 2026-12-31
Marketing Start 2021-04-02

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 705183064
Hyphenated Format 70518-3064

Supplemental Identifiers

RxCUI
197905
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 ANDA075551 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3064-0)
  • 30 TABLET in 1 BLISTER PACK (70518-3064-1)
source: ndc

Packages (2)

70518-3064-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-3064-0) 70518-3064-1 30 TABLET in 1 BLISTER PACK (70518-3064-1)

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": "3a0da39c-0adf-1571-e063-6294a90ac9be", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["9LHU78OQFD"], "rxcui": ["197905"], "spl_set_id": ["a902a95f-072a-4487-99a9-109a93f8b23c"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3064-0)", "package_ndc": "70518-3064-0", "marketing_start_date": "20210402"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3064-1)", "package_ndc": "70518-3064-1", "marketing_start_date": "20210512"}], "brand_name": "Lovastatin", "product_id": "70518-3064_3a0da39c-0adf-1571-e063-6294a90ac9be", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-3064", "generic_name": "Lovastatin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lovastatin", "active_ingredients": [{"name": "LOVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA075551", "marketing_category": "ANDA", "marketing_start_date": "20210402", "listing_expiration_date": "20261231"}