NDC 68071-3397

Lovastatin

Lovastatin

Lovastatin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals, Inc.. The primary component is Lovastatin.

Product ID68071-3397_5436442d-57ea-71f3-e054-00144ff8d46c
NDC68071-3397
Product TypeHuman Prescription Drug
Proprietary NameLovastatin
Generic NameLovastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA075636
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameLOVASTATIN
Active Ingredient Strength40 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-3397-9

90 TABLET in 1 BOTTLE (68071-3397-9)
Marketing Start Date2017-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3397-9 [68071339709]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA075636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-13
Marketing End Date2019-12-31

NDC 68071-3397-3 [68071339703]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA075636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-13
Marketing End Date2019-12-31

NDC 68071-3397-6 [68071339706]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA075636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-13
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
LOVASTATIN40 mg/1

OpenFDA Data

SPL SET ID:5436442d-57e9-71f3-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197905

    • Pharmacological Class

    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]