Indomethacin

Product NDC
71335-0992
11-digit product format
713350992
Labeler code
71335
Product ID
71335-0992_d3d7cb69-1bcd-44b0-92b8-74c48abc60bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091240
Marketing category
ANDA
Marketing start
2016-05-19
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
71335-0992-1Indomethacin20 in 1 BOTTLECAPSULE20103
71335-0992-2Indomethacin30 in 1 BOTTLECAPSULE30103
71335-0992-3Indomethacin60 in 1 BOTTLECAPSULE60103
71335-0992-4Indomethacin90 in 1 BOTTLECAPSULE90103
71335-0992-5Indomethacin21 in 1 BOTTLECAPSULE21103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0992INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250331_b1bb9349-21e4-4e6a-9916-3aac6c4d01b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNb1bb9349-21e4-4e6a-9916-3aac6c4d01b8103
197817indomethacin 25 MG Oral CapsuleSCDb1bb9349-21e4-4e6a-9916-3aac6c4d01b8103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0992-17133509920120 CAPSULE in 1 BOTTLE (71335-0992-1) 20 capsule2022-02-090000-00-00NoNoCurrent
71335-0992-27133509920230 CAPSULE in 1 BOTTLE (71335-0992-2) 30 capsule2022-02-090000-00-00NoNoCurrent
71335-0992-37133509920360 CAPSULE in 1 BOTTLE (71335-0992-3) 60 capsule2022-02-090000-00-00NoNoCurrent
71335-0992-47133509920490 CAPSULE in 1 BOTTLE (71335-0992-4) 90 capsule2022-02-090000-00-00NoNoCurrent
71335-0992-57133509920521 CAPSULE in 1 BOTTLE (71335-0992-5) 21 capsule2022-02-090000-00-00NoNoCurrent