Indomethacin

Product NDC
72162-1302
11-digit product format
721621302
Labeler code
72162
Product ID
72162-1302_c4742322-daa6-4ce7-afb1-e69f062a63fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201807
Marketing category
ANDA
Marketing start
2015-07-24
Substance
INDOMETHACIN
Active strength
75 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 formatDescriptionMarketing startSampleExclude flagStatus
72162-1302-67216213020660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1302-6) 2023-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Indomethacin Extended Release Capsules, USPBryant Ranch Prepack2025-03-31HUMAN PRESCRIPTION DRUG LABEL101