NDC 61919-303

ATORVASTATIN CALCIUM

Atorvastatin

ATORVASTATIN CALCIUM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Atorvastatin Calcium.

Product ID61919-303_676269b3-6f30-4d85-e053-2a91aa0a9a16
NDC61919-303
Product TypeHuman Prescription Drug
Proprietary NameATORVASTATIN CALCIUM
Generic NameAtorvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA090548
Labeler NameDIRECT RX
Substance NameATORVASTATIN CALCIUM
Active Ingredient Strength40 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61919-303-90

90 TABLET, FILM COATED in 1 BOTTLE (61919-303-90)
Marketing Start Date2018-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-303-90 [61919030390]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-09

NDC 61919-303-30 [61919030330]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090548
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE40 mg/1

OpenFDA Data

SPL SET ID:7a3d0c78-f0a7-0706-e053-2991aa0ae9f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 617311
  • Pharmacological Class

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

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

    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.