NDC 68382-065

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Simvastatin.

Product ID68382-065_1c0e6014-acc1-423f-bdec-6ba320111523
NDC68382-065
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA077837
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameSIMVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68382-065-05

500 TABLET, FILM COATED in 1 BOTTLE (68382-065-05)
Marketing Start Date2006-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-065-10 [68382006510]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 68382-065-16 [68382006516]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 68382-065-06 [68382006506]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 68382-065-14 [68382006514]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 68382-065-05 [68382006505]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN5 mg/1

OpenFDA Data

SPL SET ID:30fbaf9e-01cf-492a-b44f-dc81c17d7647
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312962
  • 312961

    • Pharmacological Class

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

    Medicade Reported Pricing

    68382065906 PYRIDOSTIGMINE BR 60 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065901 PYRIDOSTIGMINE BR 60 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065810 GLYBURIDE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065801 GLYBURIDE 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065705 GLYBURIDE 2.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065701 GLYBURIDE 2.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065601 GLYBURIDE 1.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382065505 GLYBURIDE-METFORMIN 5-500 MG

    Pricing Unit: EA | Drug Type:

    68382065501 GLYBURIDE-METFORMIN 5-500 MG

    Pricing Unit: EA | Drug Type:

    68382065405 GLYBURIDE-METFORMIN 2.5-500 MG

    Pricing Unit: EA | Drug Type:

    68382065401 GLYBURIDE-METFORMIN 2.5-500 MG

    Pricing Unit: EA | Drug Type:

    68382065301 GLYBURID-METFORMIN 1.25-250 MG

    Pricing Unit: EA | Drug Type:

    68382065201 ISOSORBIDE MONONIT ER 120 MG

    Pricing Unit: EA | Drug Type:

    68382065105 ISOSORBIDE MONONIT ER 60 MG TB

    Pricing Unit: EA | Drug Type:

    68382065101 ISOSORBIDE MONONIT ER 60 MG TB

    Pricing Unit: EA | Drug Type:

    68382065005 ISOSORBIDE MONONIT ER 30 MG TB

    Pricing Unit: EA | Drug Type:

    68382065001 ISOSORBIDE MONONIT ER 30 MG TB

    Pricing Unit: EA | Drug Type:

    68382006516 SIMVASTATIN 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382006510 SIMVASTATIN 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    68382006506 SIMVASTATIN 5 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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