FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
42708-004
11-digit product format
427080004
Labeler code
42708
Product ID
42708-004_45b41a94-e930-c847-e063-6394a90ad348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA205300
Marketing category
ANDA
Marketing start
2017-05-04
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310, 617311, 617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-004-302021-03-12C16284748780-1ba0f9c33-5e9e-a910-e053-dadaa90a0b85These 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
42708-004-302021-01-29C16284748780-1ba0f9c33-5e9e-a910-e053-dadaa90a0b85These 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
42708-004-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-004ATORVASTATIN CALCIUM TABLET, FILM COATED [QPHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20241128_3e59aa97-5480-41e0-86b0-047e648b976d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN3e59aa97-5480-41e0-86b0-047e648b976d8
617310atorvastatin calcium 20 MG Oral TabletPSN3e59aa97-5480-41e0-86b0-047e648b976d8
617311atorvastatin calcium 40 MG Oral TabletPSN3e59aa97-5480-41e0-86b0-047e648b976d8
617312atorvastatin 10 MG Oral TabletSCD3e59aa97-5480-41e0-86b0-047e648b976d8
617310atorvastatin 20 MG Oral TabletSCD3e59aa97-5480-41e0-86b0-047e648b976d8
617311atorvastatin 40 MG Oral TabletSCD3e59aa97-5480-41e0-86b0-047e648b976d8
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY3e59aa97-5480-41e0-86b0-047e648b976d8
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY3e59aa97-5480-41e0-86b0-047e648b976d8
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY3e59aa97-5480-41e0-86b0-047e648b976d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-004-304270800043030 TABLET, FILM COATED in 1 BOTTLE (42708-004-30) 2018-05-310000-00-00YesNoCurrent