FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
82804-144
11-digit product format
828040144
Labeler code
82804
Product ID
82804-144_c765c487-8634-4298-b907-674504aa96ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214344
Marketing category
ANDA
Marketing start
2023-09-12
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

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
82804-144-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302
82804-144-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-144-30EA - Each82804-144fc54d501-9430-4be4-8acf-19da6234774d12025-05-14
82804-144-90EA - Each82804-144786929cb-a007-4e39-a8b0-636d1e162cbb12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-144ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 2 package rows20241115_5a132b72-5318-43ab-881d-a2e51bd20bdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5a132b72-5318-43ab-881d-a2e51bd20bdc2
617312atorvastatin 10 MG Oral TabletSCD5a132b72-5318-43ab-881d-a2e51bd20bdc2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5a132b72-5318-43ab-881d-a2e51bd20bdc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-144-308280401443030 TABLET, FILM COATED in 1 BOTTLE (82804-144-30) 2024-11-08NoNoCurrent
82804-144-908280401449090 TABLET, FILM COATED in 1 BOTTLE (82804-144-90) 2024-09-18NoNoCurrent