Indomethacin

Product NDC
69238-2086
11-digit product format
692382086
Labeler code
69238
Product ID
69238-2086_46b85569-0280-40b8-8230-939ec20c8c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215399
Marketing category
ANDA
Marketing start
2025-02-26
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
Rxcui197819

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2086-3Indomethacin30 in 1 BOXSUPPOSITORY3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2086-3EA - Each69238-2086cfca136c-6827-4ac8-9b1c-5d328fed2b5212025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2086INDOMETHACIN SUPPOSITORY [AMNEAL PHARMACEUTICALS NY LLC]11Current NDC, 1 package rows20250226_8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197819indomethacin 50 MG Rectal SuppositoryPSN8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a11
197819indomethacin 50 MG Rectal SuppositorySCD8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2086-36923820860330 SUPPOSITORY in 1 BOX (69238-2086-3) 30 suppository2025-02-26NoNoHistorical