FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
70518-0186
11-digit product format
705180186
Labeler code
70518
Product ID
70518-0186_47e48249-8eb4-26a5-e063-6394a90a4330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2017-01-31
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0186-02023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-02023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-12023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-12023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-22023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-22023-03-24C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-02023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-02023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-12023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-12023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-22023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
70518-0186-22023-01-30C16284748780-1f386c64a-05ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0186-0ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-0186-1ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9017
70518-0186-2ATORVASTATIN CALCIUM28 in 1 BLISTER PACKTABLET, FILM COATED2817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0186ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250425_e91c673d-c26c-4ff1-90d2-2b9d47a8d771.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNe91c673d-c26c-4ff1-90d2-2b9d47a8d77117
617310atorvastatin 20 MG Oral TabletSCDe91c673d-c26c-4ff1-90d2-2b9d47a8d77117
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYe91c673d-c26c-4ff1-90d2-2b9d47a8d77117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0186-07051801860030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0186-0) 2017-01-31NoNoHistorical
70518-0186-17051801860190 in 1 BOTTLE, PLASTICHistorical
70518-0186-27051801860228 TABLET, FILM COATED in 1 BLISTER PACK (70518-0186-2) 2018-12-060000-00-00NoNoCurrent