FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
43063-453
11-digit product format
430630453
Labeler code
43063
Product ID
43063-453_36b1104c-098f-7f21-e063-6394a90a0f0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
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
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 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
43063-453-30ATORVASTATIN CALCIUM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-453ATORVASTATIN CALCIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]34Current NDC, Legacy NDC, 1 package rows20250302_5412835b-27c6-461f-97b9-b5bf03afe7f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN5412835b-27c6-461f-97b9-b5bf03afe7f235
617311atorvastatin 40 MG Oral TabletSCD5412835b-27c6-461f-97b9-b5bf03afe7f235
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY5412835b-27c6-461f-97b9-b5bf03afe7f235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-453-304306304533030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-453-30) 2012-05-290000-00-00NoNoCurrent