Indomethacin

Product NDC
60760-916
11-digit product format
607600916
Labeler code
60760
Product ID
60760-916_43cff215-ee28-4b44-e063-6394a90a8a11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
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
60760-916-216076009162121 CAPSULE in 1 BOTTLE, PLASTIC (60760-916-21) 21 capsule2025-02-28NoNoHistorical
60760-916-306076009163030 CAPSULE in 1 BOTTLE, PLASTIC (60760-916-30) 30 capsule2024-08-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinST. MARY'S MEDICAL PARK PHARMACY2025-11-17HUMAN PRESCRIPTION DRUG LABEL3