FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
31722-426
11-digit product format
317220426
Labeler code
31722
Product ID
31722-426_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
40 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 TRIHYDRATE40 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
31722-426-05ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5005
31722-426-10ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED10005
31722-426-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-426-05EA - Each31722-426c031b7d8-25e9-42ae-8f22-d580a90812d212024-03-12
31722-426-10EA - Each31722-426c0ae6570-544e-41ec-b4fd-906eaad3e46f12024-08-12
31722-426-90EA - Each31722-426e9fb8a6b-dcd5-4ac3-9731-96b58d02d76112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-426ATORVASTATIN 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
617311atorvastatin calcium 40 MG Oral TabletPSN200c1994-9327-e02c-e063-6394a90a593d4
617311atorvastatin 40 MG Oral TabletSCD200c1994-9327-e02c-e063-6394a90a593d4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY200c1994-9327-e02c-e063-6394a90a593d4
617311atorvastatin calcium 40 MG Oral TabletPSN76e8e69c-590f-4f74-82e1-199d8d14fa802
617311atorvastatin calcium 40 MG Oral TabletPSN57b070d1-217a-413b-9350-e2387c5c282a2
617311atorvastatin 40 MG Oral TabletSCD57b070d1-217a-413b-9350-e2387c5c282a2
617311atorvastatin 40 MG Oral TabletSCD76e8e69c-590f-4f74-82e1-199d8d14fa802
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY57b070d1-217a-413b-9350-e2387c5c282a2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY76e8e69c-590f-4f74-82e1-199d8d14fa802
617311atorvastatin calcium 40 MG Oral TabletPSN9d11f845-8e56-4251-8a1f-8f4b3843ea621
617311atorvastatin calcium 40 MG Oral TabletPSN1adc3c12-1a78-33a0-e063-6294a90a486a1
617311atorvastatin calcium 40 MG Oral TabletPSN1ea6235f-633c-af0b-e063-6294a90aad6d1
617311atorvastatin 40 MG Oral TabletSCD1ea6235f-633c-af0b-e063-6294a90aad6d1
617311atorvastatin 40 MG Oral TabletSCD1adc3c12-1a78-33a0-e063-6294a90a486a1
617311atorvastatin 40 MG Oral TabletSCD9d11f845-8e56-4251-8a1f-8f4b3843ea621
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1ea6235f-633c-af0b-e063-6294a90aad6d1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1adc3c12-1a78-33a0-e063-6294a90a486a1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY9d11f845-8e56-4251-8a1f-8f4b3843ea621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-426-0531722042605500 TABLET, FILM COATED in 1 BOTTLE (31722-426-05) 2023-09-12NoNoCurrent
31722-426-10317220426101000 TABLET, FILM COATED in 1 BOTTLE (31722-426-10) 2024-04-25NoNoCurrent
31722-426-903172204269090 TABLET, FILM COATED in 1 BOTTLE (31722-426-90) 2023-09-12NoNoCurrent