FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
59651-607
11-digit product format
596510607
Labeler code
59651
Product ID
59651-607_b9128b7d-1e45-4f05-9f0a-26bd825e402d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217118
Marketing category
ANDA
Marketing start
2024-02-13
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
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
59651-607-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5003
59651-607-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
59651-607-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903
59651-607-99Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-607ATORVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20240426_536b5e0d-1bb9-4c9d-a588-460d7647308b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN536b5e0d-1bb9-4c9d-a588-460d7647308b3
617310atorvastatin calcium 20 MG Oral TabletPSN536b5e0d-1bb9-4c9d-a588-460d7647308b3
617311atorvastatin calcium 40 MG Oral TabletPSN536b5e0d-1bb9-4c9d-a588-460d7647308b3
259255atorvastatin calcium 80 MG Oral TabletPSN536b5e0d-1bb9-4c9d-a588-460d7647308b3
617312atorvastatin 10 MG Oral TabletSCD536b5e0d-1bb9-4c9d-a588-460d7647308b3
617310atorvastatin 20 MG Oral TabletSCD536b5e0d-1bb9-4c9d-a588-460d7647308b3
617311atorvastatin 40 MG Oral TabletSCD536b5e0d-1bb9-4c9d-a588-460d7647308b3
259255atorvastatin 80 MG Oral TabletSCD536b5e0d-1bb9-4c9d-a588-460d7647308b3
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY536b5e0d-1bb9-4c9d-a588-460d7647308b3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY536b5e0d-1bb9-4c9d-a588-460d7647308b3
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY536b5e0d-1bb9-4c9d-a588-460d7647308b3
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY536b5e0d-1bb9-4c9d-a588-460d7647308b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-607-0559651060705500 TABLET, FILM COATED in 1 BOTTLE (59651-607-05) 2024-02-13NoNoCurrent
59651-607-305965106073030 TABLET, FILM COATED in 1 BOTTLE (59651-607-30) 2024-02-13NoNoCurrent
59651-607-605965106076060000 TABLET, FILM COATED in 1 BAG (59651-607-60)13-FEB-24Current
59651-607-905965106079090 TABLET, FILM COATED in 1 BOTTLE (59651-607-90) 2024-02-13NoNoCurrent
59651-607-99596510607991000 TABLET, FILM COATED in 1 BOTTLE (59651-607-99) 2024-02-13NoNoCurrent