FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
68788-4096
11-digit product format
687884096
Labeler code
68788
Product ID
68788-4096_e78ba844-97a6-4602-92b6-8190028b826d
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
2026-03-17
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 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 TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310

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
68788-4096-3Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED301
68788-4096-6Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED601
68788-4096-9Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4096-3EA - Each68788-40969aeae8c0-a253-4ae2-905c-9e23ca2874f812026-05-22
68788-4096-6EA - Each68788-409686989551-e094-47b0-b91f-62f953e0f7e412026-05-22
68788-4096-9EA - Each68788-409675771845-d480-4d1c-88f4-58246df776ab12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNe78ba844-97a6-4602-92b6-8190028b826d1
617310atorvastatin 20 MG Oral TabletSCDe78ba844-97a6-4602-92b6-8190028b826d1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYe78ba844-97a6-4602-92b6-8190028b826d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4096-36878840960330 TABLET, FILM COATED in 1 BOTTLE (68788-4096-3) 2026-03-17NoNoHistorical
68788-4096-66878840960660 TABLET, FILM COATED in 1 BOTTLE (68788-4096-6) 2026-03-17NoNoHistorical
68788-4096-96878840960990 TABLET, FILM COATED in 1 BOTTLE (68788-4096-9) 2026-03-17NoNoHistorical