FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
68788-8094
11-digit product format
687888094
Labeler code
68788
Product ID
68788-8094_e47e7e57-aa89-4ce2-8b17-4b58bfdc0af0
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
2021-10-06
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617311

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
68788-8094-1Atorvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1006
68788-8094-3Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED306
68788-8094-6Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED606
68788-8094-9Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8094-1EA - Each68788-8094aa7f002b-7417-4677-84e1-46ba7d790e4612021-11-09
68788-8094-3EA - Each68788-8094fa59ab06-dd0d-4e30-b3a7-1caad05344d312021-11-09
68788-8094-6EA - Each68788-8094e09c93ff-0998-474e-8111-fcded0c71dfb12021-11-09
68788-8094-9EA - Each68788-8094349e6d33-fae8-4092-b255-d6b99ab99c6012021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8094ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250207_21234914-e1bb-4118-8f81-4ab4a59e9e1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN21234914-e1bb-4118-8f81-4ab4a59e9e1e6
617311atorvastatin 40 MG Oral TabletSCD21234914-e1bb-4118-8f81-4ab4a59e9e1e6
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY21234914-e1bb-4118-8f81-4ab4a59e9e1e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8094-168788809401100 TABLET, FILM COATED in 1 BOTTLE (68788-8094-1) 2021-10-060000-00-00NoNoCurrent
68788-8094-36878880940330 TABLET, FILM COATED in 1 BOTTLE (68788-8094-3) 2021-10-060000-00-00NoNoCurrent
68788-8094-66878880940660 TABLET, FILM COATED in 1 BOTTLE (68788-8094-6) 2021-10-060000-00-00NoNoCurrent
68788-8094-96878880940990 TABLET, FILM COATED in 1 BOTTLE (68788-8094-9) 2021-10-060000-00-00NoNoCurrent