FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
0615-8008
11-digit product format
006158008
Labeler code
0615
Product ID
0615-8008_8763121c-ceae-4ce3-87fc-91909d586ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
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
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617311

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
0615-8008-05ATORVASTATIN CALCIUM15 in 1 BLISTER PACKTABLET, FILM COATED1535
0615-8008-07ATORVASTATIN CALCIUM7 in 1 BLISTER PACKTABLET, FILM COATED735
0615-8008-14ATORVASTATIN CALCIUM14 in 1 BLISTER PACKTABLET, FILM COATED1435
0615-8008-28ATORVASTATIN CALCIUM28 in 1 BLISTER PACKTABLET, FILM COATED2835
0615-8008-30ATORVASTATIN CALCIUM5 in 1 BLISTER PACKTABLET, FILM COATED535
0615-8008-30ATORVASTATIN CALCIUM6 in 1 BOX, UNIT-DOSETABLET, FILM COATED635
0615-8008-39ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED3035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8008ATORVASTATIN CALCIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]35Current NDC, Legacy NDC, 7 package rows20240820_40e6b63f-0a20-404a-8915-2f698877a96b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN40e6b63f-0a20-404a-8915-2f698877a96b35
617311atorvastatin 40 MG Oral TabletSCD40e6b63f-0a20-404a-8915-2f698877a96b35
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY40e6b63f-0a20-404a-8915-2f698877a96b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8008-050061580080515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-05) 2018-11-060000-00-00NoNoCurrent
0615-8008-07006158008077 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-07) 2018-11-060000-00-00NoNoCurrent
0615-8008-140061580081414 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-14) 2022-12-13NoNoHistorical
0615-8008-280061580082828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-28) 2024-04-16NoNoHistorical
0615-8008-30006158008306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8008-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2018-11-120000-00-00NoNoCurrent
0615-8008-390061580083930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-39) 2018-11-060000-00-00NoNoCurrent