FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
51655-920
11-digit product format
516550920
Labeler code
51655
Product ID
51655-920_49743995-7fc8-3d7a-e063-6394a90a0755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2014-03-11
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 SOLVATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617310

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
51655-920-302023-10-31C16284748780-19d75b9d0-d315-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
51655-920-302020-01-31C16284748780-19d75b9d0-d315-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-920-26ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-920-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
51655-920-83ATORVASTATIN CALCIUM180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-920ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20240814_0e10adb3-8d3a-412f-ae56-d9b9bed4641f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN0e10adb3-8d3a-412f-ae56-d9b9bed4641f4
617310atorvastatin 20 MG Oral TabletSCD0e10adb3-8d3a-412f-ae56-d9b9bed4641f4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY0e10adb3-8d3a-412f-ae56-d9b9bed4641f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-920-265165509202690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-26) 2022-08-17NoNoHistorical
51655-920-305165509203030 TABLET, FILM COATED in 1 BOTTLE (51655-920-30) 2014-03-11NoNoHistorical
51655-920-8351655092083180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-83) 2023-01-05NoNoHistorical