ATORVASTATIN CALCIUM

Product NDC
55154-7628
11-digit product format
551547628
Labeler code
55154
Product ID
55154-7628_c7796957-2adf-444c-b5d1-e1b3584a42f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2014-10-31
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7628-0ATORVASTATIN CALCIUM1 in 1 BLISTER PACKTABLET, FILM COATED119
55154-7628-0ATORVASTATIN CALCIUM10 in 1 BAGTABLET, FILM COATED1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7628ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]18Current NDC, Legacy NDC, 2 package rows20240726_75ea68e0-12e2-4e27-876f-f24f6e33a0b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin calcium 80 MG Oral TabletPSN75ea68e0-12e2-4e27-876f-f24f6e33a0b719
617311atorvastatin 40 MG Oral TabletSCD75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin 80 MG Oral TabletSCD75ea68e0-12e2-4e27-876f-f24f6e33a0b719
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY75ea68e0-12e2-4e27-876f-f24f6e33a0b719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7628-05515476280010 BLISTER PACK in 1 BAG (55154-7628-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2014-10-310000-00-00NoNoCurrent