Indomethacin

Product NDC
72162-1300
11-digit product format
721621300
Labeler code
72162
Product ID
72162-1300_0cac10c0-fb16-4f89-a81e-739143b6c8c8
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
72162-1300-172162130001100 CAPSULE in 1 BOTTLE (72162-1300-1) 100 capsule2023-08-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinBryant Ranch Prepack2025-03-31HUMAN PRESCRIPTION DRUG LABEL101