FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
50090-5207
11-digit product format
500905207
Labeler code
50090
Product ID
50090-5207_3d1e7129-0907-4381-bca1-2736f5bb7123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
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
Rxcui617311

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
50090-5207-0Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED307
50090-5207-1Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED907
50090-5207-2Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5207-0EA - Each50090-5207ff087fc6-c2b9-471e-af1d-c8e0f268738912022-10-06
50090-5207-1EA - Each50090-5207124aaaa5-45d8-450c-aff4-94ba1a23b0ba12022-01-06
50090-5207-2EA - Each50090-52074cbf69b3-172c-4699-83f9-df66354c7f7312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5207ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20240417_2ad89657-cc95-44a0-af6a-ee756526aa10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN2ad89657-cc95-44a0-af6a-ee756526aa107
617311atorvastatin 40 MG Oral TabletSCD2ad89657-cc95-44a0-af6a-ee756526aa107
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2ad89657-cc95-44a0-af6a-ee756526aa107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5207-05009052070030 TABLET, FILM COATED in 1 BOTTLE (50090-5207-0) 2020-10-050000-00-00NoNoCurrent
50090-5207-15009052070190 TABLET, FILM COATED in 1 BOTTLE (50090-5207-1) 2020-10-050000-00-00NoNoCurrent
50090-5207-250090520702100 TABLET, FILM COATED in 1 BOTTLE (50090-5207-2) 2023-09-13NoNoHistorical