FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68788-8683
11-digit product format
687888683
Labeler code
68788
Product ID
68788-8683_4b8d6845-ea90-4607-8650-e482cc26a5e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA214344
Marketing category
ANDA
Marketing start
2024-06-01
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, 617312

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-8683-12026-01-29C16284748780-149896155-a608-586f-e063-e6dba90add90These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
68788-8683-32026-01-29C16284748780-149896155-a608-586f-e063-e6dba90add90These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
68788-8683-62026-01-29C16284748780-149896155-a608-586f-e063-e6dba90add90These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
68788-8683-92026-01-29C16284748780-149896155-a608-586f-e063-e6dba90add90These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8683-1ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1002
68788-8683-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302
68788-8683-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED602
68788-8683-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8683-1EA - Each68788-868301ccc487-03ec-4454-bed6-3c860f0316a612024-08-12
68788-8683-3EA - Each68788-86831a2ef22d-5a95-4c8d-9c34-82a71603266a12024-08-12
68788-8683-6EA - Each68788-868328e8a72a-c95c-49e0-a508-bbcf05d53d2112024-08-12
68788-8683-9EA - Each68788-868385c8b606-872a-47a5-96bc-4960e97d111312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8683ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20240612_5327cf20-81e0-4b46-8c86-88c0ddd19c5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin calcium 20 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617312atorvastatin 10 MG Oral TabletSCD5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin 20 MG Oral TabletSCD5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5327cf20-81e0-4b46-8c86-88c0ddd19c5f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8683-168788868301100 TABLET, FILM COATED in 1 BOTTLE (68788-8683-1) 2024-06-01NoNoHistorical
68788-8683-36878886830330 TABLET, FILM COATED in 1 BOTTLE (68788-8683-3) 2024-06-01NoNoHistorical
68788-8683-66878886830660 TABLET, FILM COATED in 1 BOTTLE (68788-8683-6) 2024-06-01NoNoHistorical
68788-8683-96878886830990 TABLET, FILM COATED in 1 BOTTLE (68788-8683-9) 2024-06-01NoNoHistorical