FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
31722-425
11-digit product format
317220425
Labeler code
31722
Product ID
31722-425_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
20 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 TRIHYDRATE20 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
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
31722-425-05ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5005
31722-425-10ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED10005
31722-425-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-425-05EA - Each31722-4255402b20a-4119-4bad-8907-e0291162ba4c12024-03-12
31722-425-10EA - Each31722-4253768224f-1482-47ad-a154-b20f009f20e612024-03-12
31722-425-90EA - Each31722-42564d8da1a-8753-4866-88ad-0bbbe377a36012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-425ATORVASTATIN 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
617310atorvastatin calcium 20 MG Oral TabletPSN258d8737-0b80-7d80-e063-6394a90adc8e4
617310atorvastatin 20 MG Oral TabletSCD258d8737-0b80-7d80-e063-6394a90adc8e4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY258d8737-0b80-7d80-e063-6394a90adc8e4
617310atorvastatin calcium 20 MG Oral TabletPSNc8b186e4-28c2-4bf9-8964-5a5f3ca3a2da3
617310atorvastatin calcium 20 MG Oral TabletPSNdb32eb1a-d282-47df-afa2-f250e3c67e713
617310atorvastatin 20 MG Oral TabletSCDdb32eb1a-d282-47df-afa2-f250e3c67e713
617310atorvastatin 20 MG Oral TabletSCDc8b186e4-28c2-4bf9-8964-5a5f3ca3a2da3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYdb32eb1a-d282-47df-afa2-f250e3c67e713
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc8b186e4-28c2-4bf9-8964-5a5f3ca3a2da3
617312atorvastatin calcium 10 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin calcium 20 MG Oral TabletPSN1e9151aa-053f-a17d-e063-6294a90afea52
617310atorvastatin calcium 20 MG Oral TabletPSN5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin calcium 20 MG Oral TabletPSN4b2d0de1-50f0-4356-aa79-88696be8ac3d2
617310atorvastatin calcium 20 MG Oral TabletPSN23ac06e0-556c-c640-e063-6394a90a931d2
617312atorvastatin 10 MG Oral TabletSCD5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin 20 MG Oral TabletSCD4b2d0de1-50f0-4356-aa79-88696be8ac3d2
617310atorvastatin 20 MG Oral TabletSCD1e9151aa-053f-a17d-e063-6294a90afea52
617310atorvastatin 20 MG Oral TabletSCD23ac06e0-556c-c640-e063-6394a90a931d2
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 TabletSY1e9151aa-053f-a17d-e063-6294a90afea52
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY4b2d0de1-50f0-4356-aa79-88696be8ac3d2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5327cf20-81e0-4b46-8c86-88c0ddd19c5f2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY23ac06e0-556c-c640-e063-6394a90a931d2
617310atorvastatin calcium 20 MG Oral TabletPSN2f2152b6-790c-aa4a-e063-6294a90a3b181
617310atorvastatin calcium 20 MG Oral TabletPSN2f76cd3b-fbfa-a193-e063-6294a90a1b321
617310atorvastatin 20 MG Oral TabletSCD2f2152b6-790c-aa4a-e063-6294a90a3b181
617310atorvastatin 20 MG Oral TabletSCD2f76cd3b-fbfa-a193-e063-6294a90a1b321
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY2f2152b6-790c-aa4a-e063-6294a90a3b181
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY2f76cd3b-fbfa-a193-e063-6294a90a1b321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-425-0531722042505500 TABLET, FILM COATED in 1 BOTTLE (31722-425-05) 2023-09-12NoNoCurrent
31722-425-10317220425101000 TABLET, FILM COATED in 1 BOTTLE (31722-425-10) 2023-09-12NoNoCurrent
31722-425-903172204259090 TABLET, FILM COATED in 1 BOTTLE (31722-425-90) 2023-09-12NoNoCurrent