NDC 70518-1219

Rosuvastatin

Rosuvastatin

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

Product ID70518-1219_7929ca3c-0d17-63ff-e053-2991aa0a1c5b
NDC70518-1219
Product TypeHuman Prescription Drug
Proprietary NameRosuvastatin
Generic NameRosuvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA207616
Labeler NameREMEDYREPACK INC.
Substance NameROSUVASTATIN CALCIUM
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 70518-1219-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1219-0)
Marketing Start Date2018-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1219-1 [70518121901]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-26

NDC 70518-1219-0 [70518121900]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207616
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-18

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM5 mg/1

OpenFDA Data

SPL SET ID:eb3691d3-08ec-4472-9cf8-b2e23c47c743
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859424
  • Pharmacological Class

    • 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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