FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
70518-0224
11-digit product format
705180224
Labeler code
70518
Product ID
70518-0224_4ce7cec6-a460-e609-e063-6294a90a4b9b
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
2017-02-15
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
10 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 SOLVATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617312

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
70518-0224-0ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED3020
70518-0224-1ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020
70518-0224-2ATORVASTATIN CALCIUM28 in 1 BLISTER PACKTABLET, FILM COATED2820

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0224ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250425_d57720ab-9f83-4da9-a57f-0d55e00a605c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNd57720ab-9f83-4da9-a57f-0d55e00a605c20
617312atorvastatin 10 MG Oral TabletSCDd57720ab-9f83-4da9-a57f-0d55e00a605c20
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYd57720ab-9f83-4da9-a57f-0d55e00a605c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0224-07051802240030 in 1 BLISTER PACKHistorical
70518-0224-17051802240190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0224-1) 2017-02-16NoNoCurrent
70518-0224-27051802240228 TABLET, FILM COATED in 1 BLISTER PACK (70518-0224-2) 2018-09-170000-00-00NoNoCurrent