FDA.reportPublic FDA data

Indomethacin

Product NDC
63629-8994
11-digit product format
636298994
Labeler code
63629
Product ID
63629-8994_3b5a34fe-e05d-4320-ade2-61ea1e73a840
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
63629-8994-1Indomethacin30 in 1 BOTTLECAPSULE30102
63629-8994-2Indomethacin60 in 1 BOTTLECAPSULE60102
63629-8994-3Indomethacin90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8994-1EA - Each63629-899481641be3-9f9e-402b-aafd-02bd59c34e7012022-03-09
63629-8994-2EA - Each63629-8994447a0a54-f900-4990-9bc2-28a3dc1ffd2912022-03-09
63629-8994-3EA - Each63629-89948853308b-ddb8-4b5d-a05b-887ff0772ac612022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8994INDOMETHACIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20250330_3fd56b7d-2799-4211-9a58-c6c1dc8c70dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197818indomethacin 50 MG Oral CapsulePSN3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102
197818indomethacin 50 MG Oral CapsuleSCD3fd56b7d-2799-4211-9a58-c6c1dc8c70dc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8994-16362989940130 CAPSULE in 1 BOTTLE (63629-8994-1) 30 capsule2021-12-070000-00-00NoNoCurrent
63629-8994-26362989940260 CAPSULE in 1 BOTTLE (63629-8994-2) 60 capsule2021-12-070000-00-00NoNoCurrent
63629-8994-36362989940390 CAPSULE in 1 BOTTLE (63629-8994-3) 90 capsule2021-12-070000-00-00NoNoCurrent