FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
51655-464
11-digit product format
516550464
Labeler code
51655
Product ID
51655-464_4b450301-a1b4-378b-e063-6294a90a2d45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA209288
Marketing category
ANDA
Marketing start
2020-10-27
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
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 TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-464-522023-10-30C16284748780-1f386c649-f7b0-0266-e053-dadaa90a7c1aThese 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
51655-464-522023-01-30C16284748780-1f386c649-f7b0-0266-e053-dadaa90a7c1aThese 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
51655-464-52Atorvastatin Calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-464ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20241225_c9f55cb6-a41b-dd27-e053-2a95a90aaeb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNc9f55cb6-a41b-dd27-e053-2a95a90aaeb74
617310atorvastatin 20 MG Oral TabletSCDc9f55cb6-a41b-dd27-e053-2a95a90aaeb74
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc9f55cb6-a41b-dd27-e053-2a95a90aaeb74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-464-525165504645230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-464-52) 2020-10-270000-00-00NoNoCurrent