Indomethacin

Product NDC
53002-3051
11-digit product format
530023051
Labeler code
53002
Product ID
53002-3051_c8a043a9-2f30-4e5a-a37e-8fe6f338abf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 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
2021-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
53002-3051-22025-01-30C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
53002-3051-32025-01-30C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
53002-3051-22023-06-08C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
53002-3051-32023-06-08C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
53002-3051-22023-01-30C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965
53002-3051-32023-01-30C16284748780-1f386c64a-47c0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use INDOMETHACIN CAPSULES safely and effectively. See full prescribing information for INDOMETHACIN CAPSULES. INDOMETHACIN capsules, for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3051-2Indomethacin20 in 1 BOTTLECAPSULE206
53002-3051-3Indomethacin30 in 1 BOTTLECAPSULE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3051INDOMETHACIN CAPSULE [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20230609_281b2349-9996-4deb-abbc-1b88a957b73d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN281b2349-9996-4deb-abbc-1b88a957b73d6
197817indomethacin 25 MG Oral CapsuleSCD281b2349-9996-4deb-abbc-1b88a957b73d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3051-25300230510220 CAPSULE in 1 BOTTLE (53002-3051-2) 20 capsule2019-01-010000-00-00NoNoCurrent
53002-3051-35300230510330 CAPSULE in 1 BOTTLE (53002-3051-3) 30 capsule2019-01-010000-00-00NoNoCurrent