NDC 50228-116

Rosuvastatin

Rosuvastatin

Rosuvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sciegen Pharmaceuticals, Inc.. The primary component is Rosuvastatin.

Product ID50228-116_15b01faa-3e2c-48b7-a7a9-a0adfa2b0c35
NDC50228-116
Product TypeHuman Prescription Drug
Proprietary NameRosuvastatin
Generic NameRosuvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-24
Marketing CategoryANDA / ANDA
Application NumberANDA206381
Labeler NameScieGen Pharmaceuticals, Inc.
Substance NameROSUVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50228-116-10

1000 TABLET, FILM COATED in 1 BOTTLE (50228-116-10)
Marketing Start Date2019-04-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-116-10 [50228011610]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206381
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-24

NDC 50228-116-30 [50228011630]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206381
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-24

NDC 50228-116-90 [50228011690]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206381
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-24

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN5 mg/1

OpenFDA Data

SPL SET ID:ee4933c5-0d97-494d-ac0f-2083e0100836
Manufacturer
UNII
UPC Code
  • 0350228116305
  • 0350228118903
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    16729-284RosuvastatinRosuvastatin
    16729-285RosuvastatinRosuvastatin
    16729-286RosuvastatinRosuvastatin
    16729-287RosuvastatinRosuvastatin
    31722-882RosuvastatinRosuvastatin
    31722-883RosuvastatinRosuvastatin
    31722-884RosuvastatinRosuvastatin
    31722-885RosuvastatinRosuvastatin
    49252-061ROSUVASTATINrosuvastatin
    49252-062ROSUVASTATINrosuvastatin
    49252-063ROSUVASTATINrosuvastatin
    49252-064ROSUVASTATINrosuvastatin
    50090-2722RosuvastatinRosuvastatin
    50090-2723RosuvastatinRosuvastatin
    69238-1148RosuvastatinRosuvastatin
    69238-1146RosuvastatinRosuvastatin
    69238-1147RosuvastatinRosuvastatin
    69238-1149RosuvastatinRosuvastatin
    70518-0986RosuvastatinRosuvastatin
    70518-1219RosuvastatinRosuvastatin
    70518-1601RosuvastatinRosuvastatin
    70518-1384RosuvastatinRosuvastatin
    71205-044RosuvastatinRosuvastatin
    50090-2724RosuvastatinRosuvastatin
    50090-2725RosuvastatinRosuvastatin
    50268-711RosuvastatinRosuvastatin
    50268-709RosuvastatinRosuvastatin
    50268-710RosuvastatinRosuvastatin
    55700-574RosuvastatinRosuvastatin
    55700-575RosuvastatinRosuvastatin
    60505-2886ROSUVASTATINROSUVASTATIN
    60505-4505ROSUVASTATINROSUVASTATIN
    60505-2885ROSUVASTATINROSUVASTATIN
    60505-4504ROSUVASTATINROSUVASTATIN
    60505-2888ROSUVASTATINROSUVASTATIN
    60505-2887ROSUVASTATINROSUVASTATIN
    60505-4503ROSUVASTATINROSUVASTATIN
    60505-4502ROSUVASTATINROSUVASTATIN
    61919-786RosuvastatinRosuvastatin
    50228-116RosuvastatinRosuvastatin
    50228-117RosuvastatinRosuvastatin
    50228-119RosuvastatinRosuvastatin
    50228-118RosuvastatinRosuvastatin
    47335-984EZALLOR SPRINKLEROSUVASTATIN
    47335-985EZALLOR SPRINKLEROSUVASTATIN
    47335-986EZALLOR SPRINKLEROSUVASTATIN
    47335-987EZALLOR SPRINKLEROSUVASTATIN

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