FDA.reportPublic FDA data

Indomethacin

Product NDC
50090-0050
11-digit product format
500900050
Labeler code
50090
Product ID
50090-0050_7dfbcb28-6d02-4391-acb6-a0ce06ee90a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
Substance
INDOMETHACIN
Active strength
50 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indomethacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197817, 197818

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
50090-0050-02023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-02023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-02023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-12023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-12023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-12023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-32023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-32023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-32023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-52023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-52023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-52023-02-07C16284748780-1f386c649-a640-0266-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
50090-0050-02023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-02023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-02023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-12023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-12023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-12023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-32023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-32023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-32023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-52023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-52023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-52023-01-30C16284748780-1f386c649-a640-0266-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
50090-0050-0Indomethacin21 in 1 BOTTLECAPSULE2133
50090-0050-1Indomethacin30 in 1 BOTTLECAPSULE3033
50090-0050-3Indomethacin90 in 1 BOTTLECAPSULE9033
50090-0050-5Indomethacin15 in 1 BOTTLECAPSULE1533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0050INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 4 package rows20250403_d2997707-1541-4f5d-8c8d-70b0a13be8b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNd2997707-1541-4f5d-8c8d-70b0a13be8b233
197818indomethacin 50 MG Oral CapsulePSNd2997707-1541-4f5d-8c8d-70b0a13be8b233
197817indomethacin 25 MG Oral CapsuleSCDd2997707-1541-4f5d-8c8d-70b0a13be8b233
197818indomethacin 50 MG Oral CapsuleSCDd2997707-1541-4f5d-8c8d-70b0a13be8b233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0050-05009000500021 CAPSULE in 1 BOTTLE (50090-0050-0) 21 capsule2016-05-190000-00-00NoNoCurrent
50090-0050-15009000500130 CAPSULE in 1 BOTTLE (50090-0050-1) 30 capsule2016-05-190000-00-00NoNoCurrent
50090-0050-35009000500390 CAPSULE in 1 BOTTLE (50090-0050-3) 90 capsule2016-05-190000-00-00NoNoCurrent
50090-0050-55009000500515 in 1 BOTTLEHistorical