FDA.reportPublic FDA data

Indomethacin

Product NDC
71335-0355
11-digit product format
713350355
Labeler code
71335
Product ID
71335-0355_88a63e3e-443d-4548-858e-3dd70f3b6fe7
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indomethacin
Listing expiration
2027-12-31

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
71335-0355-1Indomethacin20 in 1 BOTTLECAPSULE20103
71335-0355-2Indomethacin30 in 1 BOTTLECAPSULE30103
71335-0355-3Indomethacin60 in 1 BOTTLECAPSULE60103
71335-0355-4Indomethacin90 in 1 BOTTLECAPSULE90103
71335-0355-5Indomethacin21 in 1 BOTTLECAPSULE21103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0355-1EA - Each71335-035529013f62-64d7-4631-8355-97d82f2a767912018-01-12
71335-0355-2EA - Each71335-0355085bd801-f913-4fc1-b7bc-8e94ad885ca212018-01-12
71335-0355-3EA - Each71335-03556723fa83-b79c-4b0a-968e-845b09d369c912018-01-12
71335-0355-4EA - Each71335-0355d85388e1-763e-4789-af75-33b16c1c979712018-01-12
71335-0355-5EA - Each71335-03558b8b22cc-ec62-462e-a699-8cd94013d32f12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0355INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240913_bf11f5a0-f2ee-499a-8d54-9d557cc66841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSNbf11f5a0-f2ee-499a-8d54-9d557cc66841103
197817indomethacin 25 MG Oral CapsuleSCDbf11f5a0-f2ee-499a-8d54-9d557cc66841103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0355-17133503550120 CAPSULE in 1 BOTTLE (71335-0355-1) 20 capsule2024-09-050000-00-00NoNoCurrent
71335-0355-27133503550230 CAPSULE in 1 BOTTLE (71335-0355-2) 30 capsule2018-03-270000-00-00NoNoCurrent
71335-0355-37133503550360 CAPSULE in 1 BOTTLE (71335-0355-3) 60 capsule2021-01-110000-00-00NoNoCurrent
71335-0355-47133503550490 CAPSULE in 1 BOTTLE (71335-0355-4) 90 capsule2024-09-050000-00-00NoNoCurrent
71335-0355-57133503550521 CAPSULE in 1 BOTTLE (71335-0355-5) 21 capsule2023-02-210000-00-00NoNoCurrent