FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
75834-257
11-digit product format
758340257
Labeler code
75834
Product ID
75834-257_4580fe3c-b524-3a14-e063-6294a90a34d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
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
ATORVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
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
75834-257-01Atorvastatin calcium1000 in 1 BOTTLETABLET100017
75834-257-25Atorvastatin calcium2500 in 1 BOTTLETABLET250017
75834-257-50Atorvastatin calcium500 in 1 BOTTLETABLET50017
75834-257-90Atorvastatin calcium90 in 1 BOTTLETABLET9017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-257ATORVASTATIN CALCIUM TABLET [NIVAGEN PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 4 package rows20250313_7c58bf4a-4a92-4db8-89bc-4de1b5831efc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617310atorvastatin calcium 20 MG Oral TabletPSN7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617311atorvastatin calcium 40 MG Oral TabletPSN7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
259255atorvastatin calcium 80 MG Oral TabletPSN7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617312atorvastatin 10 MG Oral TabletSCD7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617310atorvastatin 20 MG Oral TabletSCD7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617311atorvastatin 40 MG Oral TabletSCD7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
259255atorvastatin 80 MG Oral TabletSCD7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY7c58bf4a-4a92-4db8-89bc-4de1b5831efc17
617311atorvastatin calcium 40 MG Oral TabletPSN20f820ba-9600-4b51-bf23-8c99e815674c2
617311atorvastatin calcium 40 MG Oral TabletPSN604a011e-6c64-4895-8f6e-d28f119c4c222
617311atorvastatin 40 MG Oral TabletSCD20f820ba-9600-4b51-bf23-8c99e815674c2
617311atorvastatin 40 MG Oral TabletSCD604a011e-6c64-4895-8f6e-d28f119c4c222
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY604a011e-6c64-4895-8f6e-d28f119c4c222
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY20f820ba-9600-4b51-bf23-8c99e815674c2
617311atorvastatin calcium 40 MG Oral TabletPSNacbbd2c4-60bd-4e01-ad7a-b9b3178569f01
617311atorvastatin 40 MG Oral TabletSCDacbbd2c4-60bd-4e01-ad7a-b9b3178569f01
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYacbbd2c4-60bd-4e01-ad7a-b9b3178569f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-257-01758340257011000 TABLET in 1 BOTTLE (75834-257-01) 1000 tablet2020-08-260000-00-00NoNoCurrent
75834-257-25758340257252500 TABLET in 1 BOTTLE (75834-257-25) 2500 tablet2020-08-260000-00-00NoNoCurrent
75834-257-5075834025750500 TABLET in 1 BOTTLE (75834-257-50) 500 tablet2020-08-260000-00-00NoNoCurrent
75834-257-907583402579090 TABLET in 1 BOTTLE (75834-257-90) 90 tablet2020-08-260000-00-00NoNoCurrent