Indomethacin

Product NDC
63629-1914
11-digit product format
636291914
Labeler code
63629
Product ID
63629-1914_0aac2825-31bb-44b2-8923-f41c4e8d2c5a
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
XXE1CET956INDOMETHACIN53-86-1INDOMETHACIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-1914-163629191401100 CAPSULE in 1 BOTTLE (63629-1914-1) 100 capsule2021-01-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinBryant Ranch Prepack2024-08-19HUMAN PRESCRIPTION DRUG LABEL106