FDA.reportPublic FDA data

INDOMETHACIN EXTENDED-RELEASE

Product NDC
52959-082
11-digit product format
529590082
Labeler code
52959
Product ID
52959-082_60cd54b1-0806-8b86-e053-2a91aa0a1458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN EXTENDED-RELEASE
Dosage form
CAPSULE
Route
ORAL
Labeler
H. J. Harkins Company inc.
Application
ANDA202706
Marketing category
ANDA
Marketing start
2017-02-21
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-082-052020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-072020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-142020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-152020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-202020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-212020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-302020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458
52959-082-602020-01-31C16284748780-19d75b9d0-4387-f424-e053-dadaa90a57ce60cd54b1-0805-8b86-e053-2a91aa0a1458

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-082-05INDOMETHACIN EXTENDED-RELEASE5 in 1 CONTAINERCAPSULE51
52959-082-07INDOMETHACIN EXTENDED-RELEASE7 in 1 CONTAINERCAPSULE71
52959-082-14INDOMETHACIN EXTENDED-RELEASE14 in 1 CONTAINERCAPSULE141
52959-082-15INDOMETHACIN EXTENDED-RELEASE15 in 1 CONTAINERCAPSULE151
52959-082-20INDOMETHACIN EXTENDED-RELEASE20 in 1 CONTAINERCAPSULE201
52959-082-21INDOMETHACIN EXTENDED-RELEASE21 in 1 CONTAINERCAPSULE211
52959-082-30INDOMETHACIN EXTENDED-RELEASE30 in 1 CONTAINERCAPSULE301
52959-082-60INDOMETHACIN EXTENDED-RELEASE60 in 1 CONTAINERCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-082-07EA - Each52959-082645e6779-f78f-45f0-8ae5-d19248edab1d12018-01-12
52959-082-14EA - Each52959-08216c1e1e4-8ee8-48f8-816e-6b37d39d8e9612018-01-12
52959-082-15EA - Each52959-082557dfcbd-c3fb-47b9-9a0b-5b793a0488ef12018-01-12
52959-082-20EA - Each52959-082b80069bf-8c81-4e50-967e-c92e1fd6309412018-01-12
52959-082-21EA - Each52959-08264702707-73c3-47bf-85f5-070e2b8da9bb12018-01-12
52959-082-30EA - Each52959-082a71b71d8-3193-4696-bb4e-04e9412d6df112018-01-12
52959-082-60EA - Each52959-082c8be63e1-f64d-4e2c-afd6-578b962e2bce12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-082INDOMETHACIN EXTENDED-RELEASE CAPSULE [H. J. HARKINS COMPANY INC.]1Legacy NDC, 8 package rows20171222_60cd54b1-0805-8b86-e053-2a91aa0a1458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310992indomethacin 75 MG Extended Release Oral CapsulePSN60cd54b1-0805-8b86-e053-2a91aa0a14581
310992indomethacin 75 MG Extended Release Oral CapsuleSCD60cd54b1-0805-8b86-e053-2a91aa0a14581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-082-05529590082055 in 1 CONTAINERHistorical
52959-082-07529590082077 in 1 CONTAINERHistorical
52959-082-145295900821414 in 1 CONTAINERHistorical
52959-082-155295900821515 in 1 CONTAINERHistorical
52959-082-205295900822020 in 1 CONTAINERHistorical
52959-082-215295900822121 in 1 CONTAINERHistorical
52959-082-305295900823030 in 1 CONTAINERHistorical
52959-082-605295900826060 in 1 CONTAINERHistorical