FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
82804-056
11-digit product format
828040056
Labeler code
82804
Product ID
82804-056_acbbd2c4-60bd-4e01-ad7a-b9b3178569f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
82804-056-30Atorvastatin calcium30 in 1 BOTTLETABLET301
82804-056-60Atorvastatin calcium60 in 1 BOTTLETABLET601
82804-056-90Atorvastatin calcium90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-056-30EA - Each82804-0561887b32c-52f8-47e4-8b72-aba8671e37da12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-056ATORVASTATIN CALCIUM TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20240119_acbbd2c4-60bd-4e01-ad7a-b9b3178569f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
82804-056-308280400563030 TABLET in 1 BOTTLE (82804-056-30) 30 tablet2024-01-12NoNoCurrent
82804-056-608280400566060 TABLET in 1 BOTTLE (82804-056-60) 60 tablet2024-01-12NoNoCurrent
82804-056-908280400569090 TABLET in 1 BOTTLE (82804-056-90) 90 tablet2024-01-12NoNoCurrent