FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50228-453
11-digit product format
502280453
Labeler code
50228
Product ID
50228-453_19c6b2b4-fbba-44dd-8668-bec63b285506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA205519
Marketing category
ANDA
Marketing start
2016-05-19
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
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 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
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
50228-453-10ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100019
50228-453-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-453ATORVASTATIN CALCIUM TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240802_f2d8b5e9-6ff2-4efa-ab01-e13df29f7371.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNd1b9e56b-1632-4450-b1ca-d8bcbba3fd7c102
617311atorvastatin 40 MG Oral TabletSCDd1b9e56b-1632-4450-b1ca-d8bcbba3fd7c102
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYd1b9e56b-1632-4450-b1ca-d8bcbba3fd7c102
617312atorvastatin calcium 10 MG Oral TabletPSNf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617310atorvastatin calcium 20 MG Oral TabletPSNf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617311atorvastatin calcium 40 MG Oral TabletPSNf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
259255atorvastatin calcium 80 MG Oral TabletPSNf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617312atorvastatin 10 MG Oral TabletSCDf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617310atorvastatin 20 MG Oral TabletSCDf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617311atorvastatin 40 MG Oral TabletSCDf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
259255atorvastatin 80 MG Oral TabletSCDf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYf2d8b5e9-6ff2-4efa-ab01-e13df29f737119
617311atorvastatin calcium 40 MG Oral TabletPSNe38c2e66-801b-7c10-e053-2995a90a010b1
617311atorvastatin 40 MG Oral TabletSCDe38c2e66-801b-7c10-e053-2995a90a010b1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYe38c2e66-801b-7c10-e053-2995a90a010b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-453-10502280453101000 TABLET, FILM COATED in 1 BOTTLE (50228-453-10) 2016-05-190000-00-00NoNoCurrent
50228-453-905022804539090 TABLET, FILM COATED in 1 BOTTLE (50228-453-90) 2016-05-190000-00-00NoNoCurrent