FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
10135-653
11-digit product format
101350653
Labeler code
10135
Product ID
10135-653_024aa21f-3c16-47ba-a652-f2c9db7f5941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA205519
Marketing category
ANDA
Marketing start
2018-09-01
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
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
10135-653-052020-01-31C16284748780-19d75b9cf-e072-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN calcium tablets for oral use Initial U.S. Approval: 19 9 6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-653-05ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-653-05EA - Each10135-6533ed0b1cd-1d16-49c3-becc-67464afe3b3512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-653ATORVASTATIN CALCIUM TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20180913_64abfa40-e0ab-46ae-8c7c-7c199b89b7c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617310atorvastatin calcium 20 MG Oral TabletPSN64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617311atorvastatin calcium 40 MG Oral TabletPSN64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
259255atorvastatin calcium 80 MG Oral TabletPSN64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617312atorvastatin 10 MG Oral TabletSCD64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617310atorvastatin 20 MG Oral TabletSCD64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617311atorvastatin 40 MG Oral TabletSCD64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
259255atorvastatin 80 MG Oral TabletSCD64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY64abfa40-e0ab-46ae-8c7c-7c199b89b7c12
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY64abfa40-e0ab-46ae-8c7c-7c199b89b7c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-653-0510135065305500 in 1 BOTTLEHistorical