FDA.reportPublic FDA data

Indomethacin

Product NDC
63187-948
11-digit product format
631870948
Labeler code
63187
Product ID
63187-948_7998043a-b571-4151-8a93-6aa76884807c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
Substance
INDOMETHACIN
Active strength
25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indomethacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDOMETHACIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXXE1CET956
Rxcui197817

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-948-08Indomethacin8 in 1 BOTTLECAPSULE84
63187-948-15Indomethacin15 in 1 BOTTLECAPSULE154
63187-948-20Indomethacin20 in 1 BOTTLECAPSULE204
63187-948-30Indomethacin30 in 1 BOTTLECAPSULE304
63187-948-60Indomethacin60 in 1 BOTTLECAPSULE604
63187-948-90Indomethacin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-948-20EA - Each63187-948c886aad9-2fd0-44d3-834c-cf88e70eb3ac12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-948INDOMETHACIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220811_86c94559-b453-4e61-a76c-6962872f0655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN86c94559-b453-4e61-a76c-6962872f06554
197817indomethacin 25 MG Oral CapsuleSCD86c94559-b453-4e61-a76c-6962872f06554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-948-08631870948088 CAPSULE in 1 BOTTLE (63187-948-08) 8 capsule2018-01-010000-00-00NoNoCurrent
63187-948-156318709481515 CAPSULE in 1 BOTTLE (63187-948-15) 15 capsule2018-01-010000-00-00NoNoCurrent
63187-948-206318709482020 CAPSULE in 1 BOTTLE (63187-948-20) 20 capsule2018-01-010000-00-00NoNoCurrent
63187-948-306318709483030 CAPSULE in 1 BOTTLE (63187-948-30) 30 capsule2018-01-010000-00-00NoNoCurrent
63187-948-606318709486060 CAPSULE in 1 BOTTLE (63187-948-60) 60 capsule2018-01-010000-00-00NoNoCurrent
63187-948-906318709489090 CAPSULE in 1 BOTTLE (63187-948-90) 90 capsule2018-01-010000-00-00NoNoCurrent