NDC 50228-452

ATORVASTATIN CALCIUM

Atorvastatin Calcium

ATORVASTATIN CALCIUM 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 Atorvastatin Calcium Trihydrate.

Product ID50228-452_55396319-cf22-4c33-998d-6fb7fe9fa70f
NDC50228-452
Product TypeHuman Prescription Drug
Proprietary NameATORVASTATIN CALCIUM
Generic NameAtorvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-05-19
Marketing CategoryANDA / ANDA
Application NumberANDA205519
Labeler NameScieGen Pharmaceuticals, Inc.
Substance NameATORVASTATIN CALCIUM TRIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50228-452-05

500 TABLET, FILM COATED in 1 BOTTLE (50228-452-05)
Marketing Start Date2016-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-452-91 [50228045291]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-19
Marketing End Date2020-04-22

NDC 50228-452-90 [50228045290]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-19

NDC 50228-452-06 [50228045206]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-19
Marketing End Date2020-04-22

NDC 50228-452-05 [50228045205]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-19

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:f2d8b5e9-6ff2-4efa-ab01-e13df29f7371
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 617310
  • 617311
  • 259255
  • 617312
    • UPC Code
  • 0350228451109
  • 0350228453912
  • 0350228452069
  • 0350228451901
  • 0350228454902
  • 0350228452915

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ATORVASTATIN CALCIUM" or generic name "Atorvastatin Calcium"

    NDCBrand NameGeneric Name
    67877-514Atorvastatin CalciumAtorvastatin Calcium
    67877-512Atorvastatin CalciumAtorvastatin Calcium
    67877-511Atorvastatin CalciumAtorvastatin Calcium
    67877-513Atorvastatin CalciumAtorvastatin Calcium
    68071-1898Atorvastatin CalciumAtorvastatin Calcium
    68071-1551Atorvastatin CalciumAtorvastatin Calcium
    68071-1886ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-1695ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-1553ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-1556Atorvastatin CalciumAtorvastatin Calcium
    68071-3267ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-1885ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-1915Atorvastatin CalciumAtorvastatin Calcium
    68071-2018ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-3399Atorvastatin CalciumAtorvastatin Calcium
    68071-3374Atorvastatin CalciumAtorvastatin Calcium
    68071-3047Atorvastatin CalciumAtorvastatin Calcium
    68071-4179ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4171Atorvastatin CalciumAtorvastatin Calcium
    68071-4287Atorvastatin CalciumAtorvastatin Calcium
    68071-3167Atorvastatin CalciumAtorvastatin Calcium
    68071-4136Atorvastatin CalciumAtorvastatin Calcium
    68071-4302ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4308ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4472Atorvastatin CalciumAtorvastatin Calcium
    68071-4267ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4336ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4150Atorvastatin CalciumAtorvastatin Calcium
    68071-3371Atorvastatin CalciumAtorvastatin Calcium
    68071-4185Atorvastatin CalciumAtorvastatin Calcium
    68071-4396ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4279Atorvastatin CalciumAtorvastatin Calcium
    68071-4506Atorvastatin CalciumAtorvastatin Calcium
    68071-4220Atorvastatin CalciumAtorvastatin Calcium
    68071-4797ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4301ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4798ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4480Atorvastatin CalciumAtorvastatin Calcium
    68084-098ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68084-099ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68071-4806Atorvastatin CalciumAtorvastatin Calcium
    68071-4654Atorvastatin CalciumAtorvastatin Calcium
    68084-097ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68084-590ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    0440-7128ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68151-1013ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
    68258-6993Atorvastatin CalciumAtorvastatin Calcium
    68258-6042Atorvastatin CalciumAtorvastatin Calcium
    68258-6044Atorvastatin CalciumAtorvastatin Calcium
    68258-6043Atorvastatin CalciumAtorvastatin Calcium
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.