Atorvastatin Calcium

Product NDC
76519-1075
11-digit product format
765191075
Labeler code
76519
Product ID
76519-1075_5e88776b-1d1e-09a9-e053-2991aa0a07e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company Inc.
Application
ANDA091650
Marketing category
ANDA
Marketing start
2017-11-20
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
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
76519-1075-32020-01-31C16284748780-19d75b9d0-f385-f424-e053-dadaa90a57ce5e88776b-1d1d-09a9-e053-2991aa0a07e9
76519-1075-92020-01-31C16284748780-19d75b9d0-f385-f424-e053-dadaa90a57ce5e88776b-1d1d-09a9-e053-2991aa0a07e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1075-3Atorvastatin Calcium30 in 1 CONTAINERTABLET301
76519-1075-9Atorvastatin Calcium90 in 1 CONTAINERTABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1075ATORVASTATIN CALCIUM TABLET [H.J. HARKINS COMPANY INC.]1Legacy NDC, 2 package rows20171129_5e88776b-1d1d-09a9-e053-2991aa0a07e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5e88776b-1d1d-09a9-e053-2991aa0a07e91
617312atorvastatin 10 MG Oral TabletSCD5e88776b-1d1d-09a9-e053-2991aa0a07e91
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5e88776b-1d1d-09a9-e053-2991aa0a07e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1075-37651910750330 in 1 CONTAINERHistorical
76519-1075-97651910750990 in 1 CONTAINERHistorical