NDC 76519-1084

ATORVASTATIN CALCIUM

Atorvastatin Calcium

ATORVASTATIN CALCIUM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Company Inc.. The primary component is Atorvastatin Calcium Trihydrate.

Product ID76519-1084_5f4d4e97-fc37-abac-e053-2a91aa0aaaf8
NDC76519-1084
Product TypeHuman Prescription Drug
Proprietary NameATORVASTATIN CALCIUM
Generic NameAtorvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA205519
Labeler NameH. J. Harkins Company Inc.
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 Through2019-12-31

Packaging

NDC 76519-1084-9

90 TABLET, FILM COATED in 1 CONTAINER (76519-1084-9)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1084-3 [76519108403]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 76519-1084-9 [76519108409]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205519
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

OpenFDA Data

SPL SET ID:5f4d4e97-fc36-abac-e053-2a91aa0aaaf8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 259255
  • UPC Code
  • 0050275000069
  • 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

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