NDC 68645-263

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Legacy Pharmaceutical Packaging. The primary component is Simvastatin.

Product ID68645-263_82a864ad-1652-405f-bbfa-b8ece0089165
NDC68645-263
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA077752
Labeler NameLegacy Pharmaceutical Packaging
Substance NameSIMVASTATIN
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68645-263-54

30 TABLET, FILM COATED in 1 BOTTLE (68645-263-54)
Marketing Start Date2006-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68645-263-78 [68645026378]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-30 [68645026330]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-01 [68645026301]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-05 [68645026305]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-60 [68645026360]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-90 [68645026390]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20
Marketing End Date2012-08-28

NDC 68645-263-54 [68645026354]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN80 mg/1

OpenFDA Data

SPL SET ID:4a81b757-0a64-4ed4-86f4-57aeb349105f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200345
    • UPC Code
  • 0368645263540

    • Pharmacological Class

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

    Medicade Reported Pricing

    68645026354 SIMVASTATIN 80 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Simvastatin" or generic name "Simvastatin"

    NDCBrand NameGeneric Name
    0093-7152SimvastatinSimvastatin
    0093-7153SimvastatinSimvastatin
    0093-7154SimvastatinSimvastatin
    0093-7155SimvastatinSimvastatin
    0093-7156SimvastatinSimvastatin
    0179-0128SimvastatinSimvastatin
    0179-0240simvastatinsimvastatin
    0179-0241simvastatinsimvastatin
    0179-0242simvastatinsimvastatin
    0179-0243simvastatinsimvastatin
    0179-1897SimvastatinSimvastatin
    0179-1898SimvastatinSimvastatin
    0179-1899SimvastatinSimvastatin
    0615-6579SimvastatinSimvastatin
    0615-6580SimvastatinSimvastatin
    0615-6581SimvastatinSimvastatin
    0615-6587SimvastatinSimvastatin
    0615-6588SimvastatinSimvastatin
    0615-7704SimvastatinSimvastatin
    0615-7705SimvastatinSimvastatin
    0615-7706SimvastatinSimvastatin
    68071-1646simvastatinsimvastatin
    68071-1965simvastatinsimvastatin
    68071-1721simvastatinsimvastatin
    68071-1711simvastatinsimvastatin
    68071-2092SimvastatinSimvastatin
    68071-1990simvastatinsimvastatin
    68071-1699simvastatinsimvastatin
    68071-1868simvastatinsimvastatin
    68071-1946simvastatinsimvastatin
    68071-3115SimvastatinSimvastatin
    68071-3391simvastatinsimvastatin
    68071-3157SimvastatinSimvastatin
    68071-3289simvastatinsimvastatin
    68071-4331SIMVASTATINSIMVASTATIN
    68071-4504simvastatinsimvastatin
    68084-512SimvastatinSimvastatin
    68151-0177SimvastatinSimvastatin
    68084-511SimvastatinSimvastatin
    68180-481SIMVASTATINSIMVASTATIN
    68180-482SIMVASTATINSIMVASTATIN
    68180-465SIMVASTATINSIMVASTATIN
    68180-478SIMVASTATINSIMVASTATIN
    68180-480SIMVASTATINSIMVASTATIN
    68180-464SIMVASTATINSIMVASTATIN
    68180-479SIMVASTATINSIMVASTATIN
    68382-069SimvastatinSimvastatin
    68382-067SimvastatinSimvastatin
    68382-065SimvastatinSimvastatin
    68382-068SimvastatinSimvastatin
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