FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
50090-5184
11-digit product format
500905184
Labeler code
50090
Product ID
50090-5184_ca8233b4-7e28-4194-801a-16319bb32255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
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
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
50090-5184-02023-02-06C16284748780-1f386c649-ed1c-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
50090-5184-12023-02-06C16284748780-1f386c649-ed1c-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
50090-5184-02023-01-30C16284748780-1f386c649-ed1c-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
50090-5184-12023-01-30C16284748780-1f386c649-ed1c-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
50090-5184-0Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED307
50090-5184-1Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED907
50090-5184-2Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5184-0EA - Each50090-5184f3304b65-d567-4e2d-aec3-43498e1bc77a12022-09-12
50090-5184-1EA - Each50090-5184068ea762-4ce3-4c74-87f6-b6c92ecea8f012022-10-06
50090-5184-2EA - Each50090-518409d8b05b-6b63-4202-be7d-ae6218d2df2912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5184ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20240417_e6d068ed-f9d2-4fd1-9755-b76bea89725e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNe6d068ed-f9d2-4fd1-9755-b76bea89725e7
617312atorvastatin 10 MG Oral TabletSCDe6d068ed-f9d2-4fd1-9755-b76bea89725e7
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYe6d068ed-f9d2-4fd1-9755-b76bea89725e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5184-05009051840030 TABLET, FILM COATED in 1 BOTTLE (50090-5184-0) 2020-09-290000-00-00NoNoCurrent
50090-5184-15009051840190 TABLET, FILM COATED in 1 BOTTLE (50090-5184-1) 2020-09-290000-00-00NoNoCurrent
50090-5184-250090518402100 TABLET, FILM COATED in 1 BOTTLE (50090-5184-2) 2023-03-07NoNoHistorical