FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
68788-8693
11-digit product format
687888693
Labeler code
68788
Product ID
68788-8693_80963931-2de1-4394-8a38-21b89c209353
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
2024-06-10
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
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
68788-8693-1Atorvastatin Calcium100 in 1 BOTTLETABLET1003
68788-8693-3Atorvastatin Calcium30 in 1 BOTTLETABLET303
68788-8693-6Atorvastatin Calcium60 in 1 BOTTLETABLET603
68788-8693-9Atorvastatin Calcium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8693-1EA - Each68788-86934eb47755-9b9b-4b8c-9222-4d70bc44e81712024-08-12
68788-8693-3EA - Each68788-86933a7beb66-7e2a-4cdc-8cdf-d3055cc8420612024-08-12
68788-8693-6EA - Each68788-8693442804a8-5926-4550-aaff-e2952206079012024-08-12
68788-8693-9EA - Each68788-8693683b801d-2e67-43a3-aec8-4746e7fe570812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8693ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20250206_a92f2742-1763-4a02-94b7-e8db714eb2f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNa92f2742-1763-4a02-94b7-e8db714eb2f43
617310atorvastatin 20 MG Oral TabletSCDa92f2742-1763-4a02-94b7-e8db714eb2f43
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYa92f2742-1763-4a02-94b7-e8db714eb2f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8693-168788869301100 TABLET in 1 BOTTLE (68788-8693-1) 100 tablet2024-06-10NoNoHistorical
68788-8693-36878886930330 TABLET in 1 BOTTLE (68788-8693-3) 30 tablet2024-06-10NoNoHistorical
68788-8693-66878886930660 TABLET in 1 BOTTLE (68788-8693-6) 60 tablet2024-06-10NoNoHistorical
68788-8693-96878886930990 TABLET in 1 BOTTLE (68788-8693-9) 90 tablet2024-06-10NoNoHistorical