FDA.reportPublic FDA data

Indomethacin

Product NDC
63629-8993
11-digit product format
636298993
Labeler code
63629
Product ID
63629-8993_5274069c-1474-4285-b3f4-1217152a08c8
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
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
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
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
63629-8993-1Indomethacin30 in 1 BOTTLECAPSULE30102
63629-8993-2Indomethacin60 in 1 BOTTLECAPSULE60102
63629-8993-3Indomethacin90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8993-1EA - Each63629-8993231eadd1-6cd8-47c8-bcf7-dcb41d6e418f12022-03-09
63629-8993-2EA - Each63629-899339339f99-7389-4ec1-b1d9-2b4bcdbd473b12022-03-09
63629-8993-3EA - Each63629-8993ba4436ae-54a8-4395-8960-76b46f54ec3312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8993INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20250330_2f4a5796-5317-4caa-83e4-0595fe844df4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN2f4a5796-5317-4caa-83e4-0595fe844df4102
197817indomethacin 25 MG Oral CapsuleSCD2f4a5796-5317-4caa-83e4-0595fe844df4102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8993-16362989930130 CAPSULE in 1 BOTTLE (63629-8993-1) 30 capsule2021-12-070000-00-00NoNoCurrent
63629-8993-26362989930260 CAPSULE in 1 BOTTLE (63629-8993-2) 60 capsule2021-12-070000-00-00NoNoCurrent
63629-8993-36362989930390 CAPSULE in 1 BOTTLE (63629-8993-3) 90 capsule2021-12-070000-00-00NoNoCurrent