FDA.reportPublic FDA data

atorvastatin calcium

Product NDC
68071-3546
11-digit product format
680713546
Labeler code
68071
Product ID
68071-3546_2d3fb96f-feeb-5b60-e063-6394a90a46e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209912
Marketing category
ANDA
Marketing start
2018-06-18
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68071-3546-92025-02-03C16284748780-12cef2736-99fa-d83d-e063-dadaa90ab31fThese 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
68071-3546-92025-01-30C16284748780-12cef2736-99fa-d83d-e063-dadaa90ab31fThese 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
68071-3546-9atorvastatin calcium90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3546ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0a9d4e36-305a-2120-e063-6294a90a01bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN0a9d4e36-305a-2120-e063-6294a90a01bd2
617312atorvastatin 10 MG Oral TabletSCD0a9d4e36-305a-2120-e063-6294a90a01bd2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY0a9d4e36-305a-2120-e063-6294a90a01bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3546-96807135460990 TABLET in 1 BOTTLE (68071-3546-9) 90 tablet2023-11-20NoNoCurrent