ATORVASTATIN CALCIUM

Product NDC
63187-656
11-digit product format
631870656
Labeler code
63187
Product ID
63187-656_112b28f5-270a-4fce-9bbb-796e0deedd9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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 PROPYLENE GLYCOL SOLVATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255

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
63187-656-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED303
63187-656-60ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED603
63187-656-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-656ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20221021_957feff4-5005-4eea-bbe2-7232be65b0eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN957feff4-5005-4eea-bbe2-7232be65b0eb3
259255atorvastatin 80 MG Oral TabletSCD957feff4-5005-4eea-bbe2-7232be65b0eb3
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY957feff4-5005-4eea-bbe2-7232be65b0eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-656-306318706563030 TABLET, FILM COATED in 1 BOTTLE (63187-656-30) 2016-05-010000-00-00NoNoCurrent
63187-656-606318706566060 TABLET, FILM COATED in 1 BOTTLE (63187-656-60) 2016-05-010000-00-00NoNoCurrent
63187-656-906318706569090 TABLET, FILM COATED in 1 BOTTLE (63187-656-90) 2016-05-010000-00-00NoNoCurrent