FDA.reportPublic FDA data

Indomethacin

Product NDC
71335-0747
11-digit product format
713350747
Labeler code
71335
Product ID
71335-0747_e2ac39f9-9b68-419f-9419-d36fae4e5b5a
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
Rxcui197818

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
71335-0747-1Indomethacin21 in 1 BOTTLECAPSULE219
71335-0747-2Indomethacin42 in 1 BOTTLECAPSULE429
71335-0747-3Indomethacin30 in 1 BOTTLECAPSULE309
71335-0747-4Indomethacin60 in 1 BOTTLECAPSULE609
71335-0747-5Indomethacin90 in 1 BOTTLECAPSULE909
71335-0747-6Indomethacin14 in 1 BOTTLECAPSULE149
71335-0747-7Indomethacin20 in 1 BOTTLECAPSULE209
71335-0747-8Indomethacin10 in 1 BOTTLECAPSULE109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0747-3EA - Each71335-0747b7d307c6-424d-43d2-8fc8-a00037408c3d12018-09-05
71335-0747-7EA - Each71335-07477803baae-8404-467c-a764-5578530ddb1312018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0747INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 8 package rows20240828_a329976b-4a01-42ea-a666-0ac99ed2522e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSNa329976b-4a01-42ea-a666-0ac99ed2522e9
197818indomethacin 50 MG Oral CapsuleSCDa329976b-4a01-42ea-a666-0ac99ed2522e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0747-17133507470121 CAPSULE in 1 BOTTLE (71335-0747-1) 21 capsule2018-07-050000-00-00NoNoCurrent
71335-0747-27133507470242 CAPSULE in 1 BOTTLE (71335-0747-2) 42 capsule2021-12-270000-00-00NoNoCurrent
71335-0747-37133507470330 CAPSULE in 1 BOTTLE (71335-0747-3) 30 capsule2018-03-280000-00-00NoNoCurrent
71335-0747-47133507470460 CAPSULE in 1 BOTTLE (71335-0747-4) 60 capsule2018-04-110000-00-00NoNoCurrent
71335-0747-57133507470590 CAPSULE in 1 BOTTLE (71335-0747-5) 90 capsule2018-03-200000-00-00NoNoCurrent
71335-0747-67133507470614 CAPSULE in 1 BOTTLE (71335-0747-6) 14 capsule2021-09-160000-00-00NoNoCurrent
71335-0747-77133507470720 CAPSULE in 1 BOTTLE (71335-0747-7) 20 capsule2018-04-250000-00-00NoNoCurrent
71335-0747-87133507470810 CAPSULE in 1 BOTTLE (71335-0747-8) 10 capsule2018-04-25NoNoHistorical