FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
72189-226
11-digit product format
721890226
Labeler code
72189
Product ID
72189-226_2c283f9f-1dbb-4a4c-e063-6394a90a7953
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076477
Marketing category
ANDA
Marketing start
2021-06-01
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
72189-226-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
72189-226-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-226-30EA - Each72189-2267086b2eb-ce33-400c-807e-f13ec2e98fdc12021-12-08
72189-226-90EA - Each72189-2268887cb35-57e9-44b4-8333-6c35b338523912021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-226ATORVASTATIN CALCIUM TABLET, FILM COATED ATORVASTATIN CALCIUM TABLET [DIRECT RX]4Current NDC, Legacy NDC, 2 package rows20250121_c3b70f79-45a3-0869-e053-2a95a90a3cdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNc3b70f79-45a3-0869-e053-2a95a90a3cdb4
617312atorvastatin 10 MG Oral TabletSCDc3b70f79-45a3-0869-e053-2a95a90a3cdb4
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYc3b70f79-45a3-0869-e053-2a95a90a3cdb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-226-307218902263030 TABLET, FILM COATED in 1 BOTTLE (72189-226-30) 2021-06-010000-00-00NoNoCurrent
72189-226-907218902269090 TABLET, FILM COATED in 1 BOTTLE (72189-226-90) 2021-06-010000-00-00NoNoCurrent