FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
0615-8006
11-digit product format
006158006
Labeler code
0615
Product ID
0615-8006_bab10f79-3f7c-4f16-a0a3-417285722a61
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
10 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 SOLVATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617312

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
0615-8006-05ATORVASTATIN CALCIUM15 in 1 BLISTER PACKTABLET, FILM COATED1512
0615-8006-07ATORVASTATIN CALCIUM7 in 1 BLISTER PACKTABLET, FILM COATED712
0615-8006-30ATORVASTATIN CALCIUM5 in 1 BLISTER PACKTABLET, FILM COATED512
0615-8006-30ATORVASTATIN CALCIUM6 in 1 BOX, UNIT-DOSETABLET, FILM COATED612
0615-8006-39ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8006ATORVASTATIN CALCIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]12Current NDC, Legacy NDC, 5 package rows20240724_47709fe3-88d3-4d2e-b9db-a06dc1c2c7d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN47709fe3-88d3-4d2e-b9db-a06dc1c2c7d412
617312atorvastatin 10 MG Oral TabletSCD47709fe3-88d3-4d2e-b9db-a06dc1c2c7d412
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY47709fe3-88d3-4d2e-b9db-a06dc1c2c7d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8006-050061580060515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-05) 2016-05-160000-00-00NoNoCurrent
0615-8006-07006158006077 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-07) 2023-08-24NoNoHistorical
0615-8006-30006158006306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8006-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2016-05-200000-00-00NoNoCurrent
0615-8006-390061580063930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8006-39) 2016-05-160000-00-00NoNoCurrent