FDA.reportPublic FDA data

Indomethacin

Product NDC
71335-0107
11-digit product format
713350107
Labeler code
71335
Product ID
71335-0107_e3d83288-9aec-4595-9367-a65cc3e72724
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
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
71335-0107-1Indomethacin21 in 1 BOTTLECAPSULE2110
71335-0107-2Indomethacin42 in 1 BOTTLECAPSULE4210
71335-0107-3Indomethacin30 in 1 BOTTLECAPSULE3010
71335-0107-4Indomethacin60 in 1 BOTTLECAPSULE6010
71335-0107-5Indomethacin90 in 1 BOTTLECAPSULE9010
71335-0107-6Indomethacin14 in 1 BOTTLECAPSULE1410
71335-0107-7Indomethacin20 in 1 BOTTLECAPSULE2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0107-1EA - Each71335-010770a9fdc5-8a2b-414e-9bd3-0f1c1de34d5112018-03-08
71335-0107-2EA - Each71335-0107b503c37d-9bf1-4838-b5e0-b394e9e6625012018-03-08
71335-0107-3EA - Each71335-0107af4f94b8-b1e9-4012-888f-d95658a9678b12018-03-08
71335-0107-4EA - Each71335-0107061dd13b-426e-4a26-826f-0956a80c156212018-03-08
71335-0107-5EA - Each71335-0107e4e06268-cbf2-4064-b55a-cadceb7348b812018-03-08
71335-0107-6EA - Each71335-0107e0eb55ad-34bb-4374-8ab5-f08db3e8b04012018-03-08
71335-0107-7EA - Each71335-0107640d495e-168d-46f0-83cf-4903763765b412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0107INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 7 package rows20240828_9ce37860-407f-47c7-a64c-62b6cc729298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN9ce37860-407f-47c7-a64c-62b6cc72929810
197818indomethacin 50 MG Oral CapsuleSCD9ce37860-407f-47c7-a64c-62b6cc72929810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0107-17133501070121 CAPSULE in 1 BOTTLE (71335-0107-1) 21 capsule2021-12-270000-00-00NoNoCurrent
71335-0107-27133501070242 CAPSULE in 1 BOTTLE (71335-0107-2) 42 capsule2021-12-270000-00-00NoNoCurrent
71335-0107-37133501070330 CAPSULE in 1 BOTTLE (71335-0107-3) 30 capsule2018-03-090000-00-00NoNoCurrent
71335-0107-47133501070460 CAPSULE in 1 BOTTLE (71335-0107-4) 60 capsule2018-09-060000-00-00NoNoCurrent
71335-0107-57133501070590 CAPSULE in 1 BOTTLE (71335-0107-5) 90 capsule2018-08-160000-00-00NoNoCurrent
71335-0107-67133501070614 CAPSULE in 1 BOTTLE (71335-0107-6) 14 capsule2021-12-270000-00-00NoNoCurrent
71335-0107-77133501070720 CAPSULE in 1 BOTTLE (71335-0107-7) 20 capsule2018-09-280000-00-00NoNoCurrent