FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68071-2018
11-digit product format
680712018
Labeler code
68071
Product ID
68071-2018_1d609fda-9b99-40b3-e063-6294a90a63b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
80 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 SOLVATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255

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
68071-2018-62023-01-30C16284748780-19d75b9cf-fdb5-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68071-2018-32020-02-19C16284748780-19d75b9cf-fdb5-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68071-2018-62020-02-19C16284748780-19d75b9cf-fdb5-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68071-2018-32020-01-31C16284748780-19d75b9cf-fdb5-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68071-2018-62020-01-31C16284748780-19d75b9cf-fdb5-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2018-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
68071-2018-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2018ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20210224_46df076d-4e98-6faa-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN46df076d-4e98-6faa-e054-00144ff8d46c4
259255atorvastatin 80 MG Oral TabletSCD46df076d-4e98-6faa-e054-00144ff8d46c4
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY46df076d-4e98-6faa-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2018-36807120180330 TABLET, FILM COATED in 1 BOTTLE (68071-2018-3) 2025-01-02NoNoCurrent
68071-2018-66807120180660 TABLET, FILM COATED in 1 BOTTLE (68071-2018-6) 2017-01-240000-00-00NoNoCurrent