FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
70518-1322
11-digit product format
705181322
Labeler code
70518
Product ID
70518-1322_4faad01a-6ac6-973a-e063-6294a90a6ad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2018-07-25
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617311

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1322-0ATORVASTATIN CALCIUM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
70518-1322-1ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9022
70518-1322-2ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1322-3ATORVASTATIN CALCIUM45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4522
70518-1322-4ATORVASTATIN CALCIUM28 in 1 BLISTER PACKTABLET, FILM COATED2822
70518-1322-5ATORVASTATIN CALCIUM60 in 1 BLISTER PACKTABLET, FILM COATED6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1322-1EA - Each70518-1322aac59c96-c31f-4bfa-8cd1-31181c92ab5012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1322ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 6 package rows20250521_303989c9-823e-4bcb-a7b3-7024fd0d3a38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN303989c9-823e-4bcb-a7b3-7024fd0d3a3822
617311atorvastatin 40 MG Oral TabletSCD303989c9-823e-4bcb-a7b3-7024fd0d3a3822
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY303989c9-823e-4bcb-a7b3-7024fd0d3a3822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1322-07051813220030 in 1 BOTTLE, PLASTICHistorical
70518-1322-17051813220190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1322-1) 2018-07-250000-00-00NoNoCurrent
70518-1322-27051813220230 TABLET, FILM COATED in 1 BLISTER PACK (70518-1322-2) 2018-07-250000-00-00NoNoCurrent
70518-1322-37051813220345 in 1 BOTTLE, PLASTICHistorical
70518-1322-47051813220428 TABLET, FILM COATED in 1 BLISTER PACK (70518-1322-4) 2020-08-200000-00-00NoNoCurrent
70518-1322-57051813220560 TABLET, FILM COATED in 1 BLISTER PACK (70518-1322-5) 2026-04-17NoNoHistorical