NDC 65862-054

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Simvastatin.

Product ID65862-054_10928f6e-d9d3-4481-b9de-4d6ab584f6a8
NDC65862-054
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA077691
Labeler NameAurobindo Pharma Limited
Substance NameSIMVASTATIN
Active Ingredient Strength80 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65862-054-00

100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00)
Marketing Start Date2006-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-054-00 [65862005400]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65862-054-90 [65862005490]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 65862-054-99 [65862005499]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 65862-054-30 [65862005430]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 65862-054-45 [65862005445]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65862-054-39 [65862005439]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 65862-054-23 [65862005423]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-09-03
Marketing End Date2011-08-29

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN80 mg/1

Medicade Reported Pricing

65862054999 VALSARTAN-HYDROCHLOROTHIAZIDE 160-25 MG TAB

Pricing Unit: EA | Drug Type:

65862054990 VALSARTAN-HYDROCHLOROTHIAZIDE 160-25 MG TAB

Pricing Unit: EA | Drug Type:

65862054899 VALSARTAN-HYDROCHLOROTHIAZIDE 160-12.5 MG TAB

Pricing Unit: EA | Drug Type:

65862054890 VALSARTAN-HYDROCHLOROTHIAZIDE 160-12.5 MG TAB

Pricing Unit: EA | Drug Type:

65862054799 VALSARTAN-HYDROCHLOROTHIAZIDE 80-12.5 MG TAB

Pricing Unit: EA | Drug Type:

65862054790 VALSARTAN-HYDROCHLOROTHIAZIDE 80-12.5 MG TAB

Pricing Unit: EA | Drug Type:

65862005499 SIMVASTATIN 80 MG TABLET

Pricing Unit: EA | Drug Type:

65862005490 SIMVASTATIN 80 MG TABLET

Pricing Unit: EA | Drug Type:

65862005439 SIMVASTATIN 80 MG TABLET

Pricing Unit: EA | Drug Type:

65862005430 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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