FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
50090-5634
11-digit product format
500905634
Labeler code
50090
Product ID
50090-5634_25b440e3-4eff-4c68-bd46-78d143e3ae55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204991
Marketing category
ANDA
Marketing start
2020-09-24
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

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
50090-5634-02023-02-06C16284748780-1f386c64a-073f-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
50090-5634-12023-02-06C16284748780-1f386c64a-073f-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
50090-5634-02023-01-30C16284748780-1f386c64a-073f-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
50090-5634-12023-01-30C16284748780-1f386c64a-073f-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
50090-5634-0Atorvastatin Calcium30 in 1 BOTTLETABLET303
50090-5634-1Atorvastatin Calcium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5634-0EA - Each50090-5634803e0b8b-615b-4755-9e4b-b0f01b388a4112022-10-06
50090-5634-1EA - Each50090-5634e494b1f9-d9e5-44e6-911a-1f8f1d01ea1412022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5634ATORVASTATIN CALCIUM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_d3f27113-785c-419e-955a-d6782fade438.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNd3f27113-785c-419e-955a-d6782fade4383
617310atorvastatin 20 MG Oral TabletSCDd3f27113-785c-419e-955a-d6782fade4383
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYd3f27113-785c-419e-955a-d6782fade4383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5634-05009056340030 TABLET in 1 BOTTLE (50090-5634-0) 30 tablet2021-09-030000-00-00NoNoCurrent
50090-5634-15009056340190 TABLET in 1 BOTTLE (50090-5634-1) 90 tablet2021-09-090000-00-00NoNoCurrent