NDC 73308-354

SIMVASTATIN

Simvastatin

SIMVASTATIN is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Ayurax. The primary component is Simvastatin.

Product ID73308-354_baedf4e4-b945-48b1-9191-a772563f3bab
NDC73308-354
Product TypeHuman Prescription Drug
Proprietary NameSIMVASTATIN
Generic NameSimvastatin
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-12-28
Marketing CategoryNDA / NDA
Application NumberNDA206679
Labeler NameAyurax
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/5mL
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 73308-354-01

75 mL in 1 BOTTLE, GLASS (73308-354-01)
Marketing Start Date2019-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 73308-354-01 [73308035401]

SIMVASTATIN SUSPENSION
Marketing CategoryNDA
Application NumberNDA206679
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-28
Marketing End Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/5mL

OpenFDA Data

SPL SET ID:791bd873-4a72-414b-96a2-7798bc00fe85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1790679
    • UPC Code
  • 0373308354015

    • Pharmacological Class

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

    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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