FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
68788-4008
11-digit product format
687884008
Labeler code
68788
Product ID
68788-4008_4ff0d618-cde4-49ae-8bcb-98dafc3ecdba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211933
Marketing category
ANDA
Marketing start
2025-08-08
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4008-1Atorvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1001
68788-4008-3Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED301
68788-4008-6Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED601
68788-4008-9Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4008-1EA - Each68788-400816bef338-b44a-4e3c-a6e6-c707d70e36da12025-11-13
68788-4008-3EA - Each68788-400808f09fcf-5cf7-4bdd-b6a6-76d03c2a781a12025-11-13
68788-4008-6EA - Each68788-400802b68d7b-3b7c-4290-aeff-0565f0d975c112025-11-13
68788-4008-9EA - Each68788-4008bf744188-e155-4a27-b339-f0e39ae5c7aa12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1
617312atorvastatin 10 MG Oral TabletSCD4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4008-168788400801100 TABLET, FILM COATED in 1 BOTTLE (68788-4008-1) 2025-08-08NoNoHistorical
68788-4008-36878840080330 TABLET, FILM COATED in 1 BOTTLE (68788-4008-3) 2025-08-08NoNoHistorical
68788-4008-66878840080660 TABLET, FILM COATED in 1 BOTTLE (68788-4008-6) 2025-08-08NoNoHistorical
68788-4008-96878840080990 TABLET, FILM COATED in 1 BOTTLE (68788-4008-9) 2025-08-08NoNoHistorical