NDC 70518-1514

ATORVASTATIN CALCIUM

Atorvastatin Calcium

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

Product ID70518-1514_789cf5fb-eee9-6647-e053-2a91aa0a8449
NDC70518-1514
Product TypeHuman Prescription Drug
Proprietary NameATORVASTATIN CALCIUM
Generic NameAtorvastatin Calcium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA090548
Labeler NameREMEDYREPACK 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 70518-1514-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1514-0)
Marketing Start Date2018-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1514-0 [70518151400]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090548
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-10

NDC 70518-1514-1 [70518151401]

ATORVASTATIN CALCIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090548
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-19

Drug Details

Active Ingredients

IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

OpenFDA Data

SPL SET ID:7050dd33-a547-4e07-a914-56267ead67ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 259255
  • Pharmacological Class

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