FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
72189-531
11-digit product format
721890531
Labeler code
72189
Product ID
72189-531_4c5d2d2b-9b9d-3a37-e063-6294a90a4137
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA213853
Marketing category
ANDA
Marketing start
2024-01-04
Substance
ATORVASTATIN
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
Rxcui617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72189-531-30Atorvastatin Calcium30 in 1 BOTTLETABLET302
72189-531-90Atorvastatin Calcium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-531-90EA - Each72189-531358e44df-9a7b-4d4e-828a-e5e339f4639e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-531ATORVASTATIN CALCIUM TABLET [DIRECT_RX]1Current NDC, 2 package rows20240106_0e24e7cb-1949-6686-e063-6394a90a4760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN0e24e7cb-1949-6686-e063-6394a90a47602
617312atorvastatin 10 MG Oral TabletSCD0e24e7cb-1949-6686-e063-6394a90a47602
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY0e24e7cb-1949-6686-e063-6394a90a47602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-531-307218905313030 TABLET in 1 BOTTLE (72189-531-30) 30 tablet2024-01-04NoNoHistorical
72189-531-907218905319090 TABLET in 1 BOTTLE (72189-531-90) 90 tablet2024-01-04NoNoHistorical