FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
61919-258
11-digit product format
619190258
Labeler code
61919
Product ID
61919-258_f21263ee-3266-b481-e053-2995a90a6554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091650
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-258-302025-01-30C16284748780-12cef2736-8dcf-d83d-e063-dadaa90ab31fATORVASTATIN CALCIUM
61919-258-902025-01-30C16284748780-12cef2736-8dcf-d83d-e063-dadaa90ab31fATORVASTATIN CALCIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-258-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET306
61919-258-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-258-30EA - Each61919-258702eda7f-9c09-4b56-b87b-069743d66a8f12016-02-04
61919-258-90EA - Each61919-25885dc87ea-e87b-422e-889b-19cb10feed7c12019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atorvastatin CalciumACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET [DIRECTRX]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET [DIRECTRX]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET [DIRECTRX]1
crospovidoneINACTIVE INGREDIENT68401960MKATORVASTATIN CALCIUM TABLET [DIRECTRX]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET [DIRECTRX]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET [DIRECTRX]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302ATORVASTATIN CALCIUM TABLET [DIRECTRX]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET [DIRECTRX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET [DIRECTRX]1
methyl alcoholINACTIVE INGREDIENTY4S76JWI15ATORVASTATIN CALCIUM TABLET [DIRECTRX]1
methylene chlorideINACTIVE INGREDIENT588X2YUY0AATORVASTATIN CALCIUM TABLET [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET [DIRECTRX]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOATORVASTATIN CALCIUM TABLET [DIRECTRX]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JATORVASTATIN CALCIUM TABLET [DIRECTRX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-258ATORVASTATIN CALCIUM TABLET [DIRECT_RX]6Legacy NDC, 2 package rows20230418_33b2b42d-60b1-47df-9df9-9965e13ece9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN33b2b42d-60b1-47df-9df9-9965e13ece9f6
617310atorvastatin 20 MG Oral TabletSCD33b2b42d-60b1-47df-9df9-9965e13ece9f6
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY33b2b42d-60b1-47df-9df9-9965e13ece9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-258-306191902583030 TABLET in 1 BOTTLE (61919-258-30) 30 tablet2019-09-190000-00-00NoNoCurrent
61919-258-906191902589090 TABLET in 1 BOTTLE (61919-258-90) 90 tablet2015-01-010000-00-00NoNoCurrent