NDC 76519-1075

Atorvastatin Calcium

Atorvastatin Calcium

Atorvastatin Calcium is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Atorvastatin Calcium.

Product ID76519-1075_5e88776b-1d1e-09a9-e053-2991aa0a07e9
NDC76519-1075
Product TypeHuman Prescription Drug
Proprietary NameAtorvastatin Calcium
Generic NameAtorvastatin Calcium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-11-20
Marketing CategoryANDA / ANDA
Application NumberANDA091650
Labeler NameH.J. Harkins Company Inc.
Substance NameATORVASTATIN CALCIUM
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76519-1075-9

90 TABLET in 1 CONTAINER (76519-1075-9)
Marketing Start Date2017-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1075-3 [76519107503]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA091650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-20
Inactivation Date2020-01-31

NDC 76519-1075-9 [76519107509]

Atorvastatin Calcium TABLET
Marketing CategoryANDA
Application NumberANDA091650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM10 mg/1

OpenFDA Data

SPL SET ID:5e88776b-1d1d-09a9-e053-2991aa0a07e9
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 617312
  • 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.