Indomethacin

Product NDC
63629-1913
11-digit product format
636291913
Labeler code
63629
Product ID
63629-1913_6404b784-3719-42d0-83b2-c29fbc7ef532
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
XXE1CET956INDOMETHACIN53-86-1INDOMETHACIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-1913-163629191301100 CAPSULE in 1 BOTTLE (63629-1913-1) 100 capsule2021-01-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinBryant Ranch Prepack2024-11-20HUMAN PRESCRIPTION DRUG LABEL107