FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
68788-8842
11-digit product format
687888842
Labeler code
68788
Product ID
68788-8842_bb825db4-3798-4d69-8559-46b3ab0c8bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209912
Marketing category
ANDA
Marketing start
2025-03-20
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8842-3Atorvastatin Calcium30 in 1 BOTTLETABLET301
68788-8842-6Atorvastatin Calcium60 in 1 BOTTLETABLET601
68788-8842-9Atorvastatin Calcium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8842-3EA - Each68788-8842ae07c610-7287-45a1-805b-25d77fc965b912025-05-14
68788-8842-6EA - Each68788-8842f88e03e2-8560-49a3-a6af-a8fed8aa521c12025-05-14
68788-8842-9EA - Each68788-884278ca4361-194e-4c18-924b-1f7d1af4680c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8842ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250322_bb825db4-3798-4d69-8559-46b3ab0c8bd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNbb825db4-3798-4d69-8559-46b3ab0c8bd91
617312atorvastatin 10 MG Oral TabletSCDbb825db4-3798-4d69-8559-46b3ab0c8bd91
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYbb825db4-3798-4d69-8559-46b3ab0c8bd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8842-36878888420330 TABLET in 1 BOTTLE (68788-8842-3) 30 tablet2025-03-20NoNoCurrent
68788-8842-66878888420660 TABLET in 1 BOTTLE (68788-8842-6) 60 tablet2025-03-20NoNoCurrent
68788-8842-96878888420990 TABLET in 1 BOTTLE (68788-8842-9) 90 tablet2025-03-20NoNoCurrent