FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
50090-6054
11-digit product format
500906054
Labeler code
50090
Product ID
50090-6054_6a5806cd-a79c-44aa-9ed5-2c8831606df0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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 TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6054-0Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED305
50090-6054-1Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED905
50090-6054-2Atorvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6054-0EA - Each50090-60540cbdba1c-558a-4fd4-a4fb-801afba701cd12022-10-06
50090-6054-1EA - Each50090-60548af1719a-4e91-450c-8ed9-999b050b308012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6054ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20230414_01eadde8-37f3-4474-995f-22c1a65adf12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN01eadde8-37f3-4474-995f-22c1a65adf125
259255atorvastatin 80 MG Oral TabletSCD01eadde8-37f3-4474-995f-22c1a65adf125
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY01eadde8-37f3-4474-995f-22c1a65adf125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6054-05009060540030 TABLET, FILM COATED in 1 BOTTLE (50090-6054-0) 2022-08-240000-00-00NoNoCurrent
50090-6054-15009060540190 TABLET, FILM COATED in 1 BOTTLE (50090-6054-1) 2022-08-24NoNoHistorical
50090-6054-250090605402100 TABLET, FILM COATED in 1 BOTTLE (50090-6054-2) 2023-04-03NoNoHistorical