Indomethacin

Product NDC
71335-1568
11-digit product format
713351568
Labeler code
71335
Product ID
71335-1568_a78e0fc3-6693-4308-82ed-11084d6d5d62
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
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1568-1Indomethacin21 in 1 BOTTLECAPSULE214
71335-1568-2Indomethacin42 in 1 BOTTLECAPSULE424
71335-1568-3Indomethacin30 in 1 BOTTLECAPSULE304
71335-1568-4Indomethacin60 in 1 BOTTLECAPSULE604
71335-1568-5Indomethacin90 in 1 BOTTLECAPSULE904
71335-1568-6Indomethacin14 in 1 BOTTLECAPSULE144
71335-1568-7Indomethacin20 in 1 BOTTLECAPSULE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1568INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 7 package rows20250331_67b16cf2-e24c-4fe3-8d74-e63549b7659f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197818indomethacin 50 MG Oral CapsulePSN67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197817indomethacin 25 MG Oral CapsuleSCD67b16cf2-e24c-4fe3-8d74-e63549b7659f4
197818indomethacin 50 MG Oral CapsuleSCD67b16cf2-e24c-4fe3-8d74-e63549b7659f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1568-17133515680121 CAPSULE in 1 BOTTLE (71335-1568-1) 21 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-27133515680242 CAPSULE in 1 BOTTLE (71335-1568-2) 42 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-37133515680330 CAPSULE in 1 BOTTLE (71335-1568-3) 30 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-47133515680460 CAPSULE in 1 BOTTLE (71335-1568-4) 60 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-57133515680590 CAPSULE in 1 BOTTLE (71335-1568-5) 90 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-67133515680614 CAPSULE in 1 BOTTLE (71335-1568-6) 14 capsule2016-05-190000-00-00NoNoCurrent
71335-1568-77133515680720 CAPSULE in 1 BOTTLE (71335-1568-7) 20 capsule2016-05-190000-00-00NoNoCurrent