FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
82804-026
11-digit product format
828040026
Labeler code
82804
Product ID
82804-026_ba7a8604-93bb-4b82-b160-328ed17f89f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
82804-026-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED301
82804-026-60Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED601
82804-026-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-026-90EA - Each82804-0265ad07397-6539-409a-b230-1a057037602512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-026ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20231019_ba7a8604-93bb-4b82-b160-328ed17f89f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNba7a8604-93bb-4b82-b160-328ed17f89f91
617311atorvastatin 40 MG Oral TabletSCDba7a8604-93bb-4b82-b160-328ed17f89f91
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYba7a8604-93bb-4b82-b160-328ed17f89f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-026-308280400263030 TABLET, FILM COATED in 1 BOTTLE (82804-026-30) 2023-10-13NoNoCurrent
82804-026-608280400266060 TABLET, FILM COATED in 1 BOTTLE (82804-026-60) 2023-10-13NoNoCurrent
82804-026-908280400269090 TABLET, FILM COATED in 1 BOTTLE (82804-026-90) 2023-10-13NoNoCurrent