FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
31722-424
11-digit product format
317220424
Labeler code
31722
Product ID
31722-424_3afbe0e5-4ded-60ee-e063-6294a90a13a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214344
Marketing category
ANDA
Marketing start
2023-09-12
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
Rxcui259255, 617310, 617311, 617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
31722-424-05ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5005
31722-424-10ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED10005
31722-424-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-424ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]4Current NDC, 3 package rows20240929_25c8f92f-9cb6-482b-82e1-16ad7c94e7b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617310atorvastatin calcium 20 MG Oral TabletPSN25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617311atorvastatin calcium 40 MG Oral TabletPSN25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
259255atorvastatin calcium 80 MG Oral TabletPSN25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617312atorvastatin 10 MG Oral TabletSCD25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617310atorvastatin 20 MG Oral TabletSCD25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617311atorvastatin 40 MG Oral TabletSCD25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
259255atorvastatin 80 MG Oral TabletSCD25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY25c8f92f-9cb6-482b-82e1-16ad7c94e7b35
617312atorvastatin calcium 10 MG Oral TabletPSN301ef8f1-6b5f-234b-e063-6294a90ad2d34
617312atorvastatin 10 MG Oral TabletSCD301ef8f1-6b5f-234b-e063-6294a90ad2d34
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY301ef8f1-6b5f-234b-e063-6294a90ad2d34
617312atorvastatin calcium 10 MG Oral TabletPSN5a132b72-5318-43ab-881d-a2e51bd20bdc2
617312atorvastatin calcium 10 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin calcium 20 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617312atorvastatin 10 MG Oral TabletSCD5a132b72-5318-43ab-881d-a2e51bd20bdc2
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 TabletSY5a132b72-5318-43ab-881d-a2e51bd20bdc2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617312atorvastatin calcium 10 MG Oral TabletPSN2de6b9b3-8f3c-599e-e063-6394a90aee601
617312atorvastatin calcium 10 MG Oral TabletPSN251828ae-7519-35c2-e063-6394a90a71ea1
617312atorvastatin calcium 10 MG Oral TabletPSN17e3997b-1594-6a0e-e063-6394a90a372e1
617312atorvastatin calcium 10 MG Oral TabletPSNf15094eb-3161-441e-b8ea-c33db2af6b501
617312atorvastatin 10 MG Oral TabletSCDf15094eb-3161-441e-b8ea-c33db2af6b501
617312atorvastatin 10 MG Oral TabletSCD2de6b9b3-8f3c-599e-e063-6394a90aee601
617312atorvastatin 10 MG Oral TabletSCD17e3997b-1594-6a0e-e063-6394a90a372e1
617312atorvastatin 10 MG Oral TabletSCD251828ae-7519-35c2-e063-6394a90a71ea1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2de6b9b3-8f3c-599e-e063-6394a90aee601
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY251828ae-7519-35c2-e063-6394a90a71ea1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYf15094eb-3161-441e-b8ea-c33db2af6b501
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY17e3997b-1594-6a0e-e063-6394a90a372e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-424-0531722042405500 TABLET, FILM COATED in 1 BOTTLE (31722-424-05) 2023-09-12NoNoCurrent
31722-424-10317220424101000 TABLET, FILM COATED in 1 BOTTLE (31722-424-10) 2023-09-12NoNoCurrent
31722-424-903172204249090 TABLET, FILM COATED in 1 BOTTLE (31722-424-90) 2023-09-12NoNoCurrent