ATORVASTATIN CALCIUM

Product NDC
61919-531
11-digit product format
619190531
Labeler code
61919
Product ID
61919-531_948f88e2-51e7-9965-e053-2995a90a161a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRX
Application
ANDA090548
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-531-302023-01-30C16284748780-1f386c649-b272-0266-e053-dadaa90a7c1aATORVASTATIN CALCIUM
61919-531-902023-01-30C16284748780-1f386c649-b272-0266-e053-dadaa90a7c1aATORVASTATIN CALCIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-531-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302
61919-531-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-531-30EA - Each61919-531648e10da-447c-4de6-99bd-28beaabaaa6512019-09-05
61919-531-90EA - Each61919-5316ab6116d-977e-4b13-9226-0dba4a796d0b12019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-531ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]2Legacy NDC, 2 package rows20191101_6b04e4bc-fa4b-4b5d-9f3d-fc620cdae43a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN6b04e4bc-fa4b-4b5d-9f3d-fc620cdae43a2
259255atorvastatin 80 MG Oral TabletSCD6b04e4bc-fa4b-4b5d-9f3d-fc620cdae43a2
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6b04e4bc-fa4b-4b5d-9f3d-fc620cdae43a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-531-306191905313030 TABLET, FILM COATED in 1 BOTTLE (61919-531-30) 2015-01-010000-00-00NoNoCurrent
61919-531-906191905319090 TABLET, FILM COATED in 1 BOTTLE (61919-531-90) 2015-01-010000-00-00NoNoCurrent