FDA.reportPublic FDA data

Indomethacin

Product NDC
50090-0052
11-digit product format
500900052
Labeler code
50090
Product ID
50090-0052_1edd76e1-7f86-417f-b4b2-8e9d443cd1c0
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
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
2022-12-31
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
50090-0052-02023-02-07C16284748780-1f386c649-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
50090-0052-02023-02-07C16284748780-1f386c649-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
50090-0052-02023-02-07C16284748780-1f386c649-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
50090-0052-12023-02-07C16284748780-1f386c649-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
50090-0052-12023-02-07C16284748780-1f386c649-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
50090-0052-12023-02-07C16284748780-1f386c649-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
50090-0052-32023-02-07C16284748780-1f386c649-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
50090-0052-32023-02-07C16284748780-1f386c649-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
50090-0052-32023-02-07C16284748780-1f386c649-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
50090-0052-42023-02-07C16284748780-1f386c649-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
50090-0052-42023-02-07C16284748780-1f386c649-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
50090-0052-42023-02-07C16284748780-1f386c649-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
50090-0052-72023-02-07C16284748780-1f386c649-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
50090-0052-72023-02-07C16284748780-1f386c649-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
50090-0052-72023-02-07C16284748780-1f386c649-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
50090-0052-02023-01-30C16284748780-1f386c649-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
50090-0052-02023-01-30C16284748780-1f386c649-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
50090-0052-02023-01-30C16284748780-1f386c649-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
50090-0052-12023-01-30C16284748780-1f386c649-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
50090-0052-12023-01-30C16284748780-1f386c649-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
50090-0052-12023-01-30C16284748780-1f386c649-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
50090-0052-32023-01-30C16284748780-1f386c649-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
50090-0052-32023-01-30C16284748780-1f386c649-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
50090-0052-32023-01-30C16284748780-1f386c649-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
50090-0052-42023-01-30C16284748780-1f386c649-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
50090-0052-42023-01-30C16284748780-1f386c649-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
50090-0052-42023-01-30C16284748780-1f386c649-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
50090-0052-72023-01-30C16284748780-1f386c649-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
50090-0052-72023-01-30C16284748780-1f386c649-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
50090-0052-72023-01-30C16284748780-1f386c649-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
50090-0052-0Indomethacin20 in 1 BOTTLECAPSULE2033
50090-0052-1Indomethacin30 in 1 BOTTLECAPSULE3033
50090-0052-3Indomethacin100 in 1 BOTTLECAPSULE10033
50090-0052-4Indomethacin15 in 1 BOTTLECAPSULE1533
50090-0052-7Indomethacin60 in 1 BOTTLECAPSULE6033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0052-1EA - Each50090-00522c39fd1e-9bb0-42e1-9105-af4925e6e35612021-05-05
50090-0052-3EA - Each50090-00525c7ea52e-56dc-42bd-9ab9-38e08c26a3aa12021-05-05
50090-0052-7EA - Each50090-005247d96971-8b6e-42c7-ae04-0ff8e50b9af912024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INDOMETHACINACTIVE INGREDIENTXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
INDOMETHACINACTIVE MOIETYXXE1CET956INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0052INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS]27Legacy NDC, 5 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
50090-0052-05009000520020 CAPSULE in 1 BOTTLE (50090-0052-0) 20 capsule2016-05-190000-00-00NoNoCurrent
50090-0052-15009000520130 CAPSULE in 1 BOTTLE (50090-0052-1) 30 capsule2016-05-190000-00-00NoNoCurrent
50090-0052-350090005203100 CAPSULE in 1 BOTTLE (50090-0052-3) 100 capsule2016-05-190000-00-00NoNoCurrent
50090-0052-45009000520415 CAPSULE in 1 BOTTLE (50090-0052-4) 15 capsule2016-05-190000-00-00NoNoCurrent
50090-0052-75009000520760 CAPSULE in 1 BOTTLE (50090-0052-7) 60 capsule2016-05-190000-00-00NoNoCurrent