NDC 69844-004

Atorvastatin Calcium

Atorvastatin Calcium, Film Coated

Atorvastatin Calcium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Graviti Pharmaceuticals Private Limited. The primary component is Atorvastatin Calcium Trihydrate.

Product ID69844-004_0c3ea528-7072-43c0-a370-aff73b9c4412
NDC69844-004
Product TypeHuman Prescription Drug
Proprietary NameAtorvastatin Calcium
Generic NameAtorvastatin Calcium, Film Coated
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-18
Marketing CategoryANDA / ANDA
Application NumberANDA209912
Labeler NameGraviti Pharmaceuticals Private Limited
Substance NameATORVASTATIN CALCIUM TRIHYDRATE
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 69844-004-01

30 TABLET in 1 BOTTLE (69844-004-01)
Marketing Start Date2018-06-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69844-004-03 [69844000403]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA209912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18

NDC 69844-004-04 [69844000404]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA209912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18

NDC 69844-004-01 [69844000401]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA209912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18

NDC 69844-004-02 [69844000402]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA209912
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-18

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

OpenFDA Data

SPL SET ID:4d7150a0-9593-46ab-b8a2-8f6fe0e483b6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 617310
  • 617311
  • 259255
  • 617312
    • UPC Code
  • 0369844002015

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Atorvastatin Calcium" or generic name "Atorvastatin Calcium, Film Coated"

    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
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