Indomethacin

Product NDC
71335-1568
11-digit product format
713351568
Labeler code
71335
Product ID
71335-1568_a78e0fc3-6693-4308-82ed-11084d6d5d62
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
71335-1568-17133515680121 CAPSULE in 1 BOTTLE (71335-1568-1) 21 capsule2016-05-19NoNoHistorical
71335-1568-27133515680242 CAPSULE in 1 BOTTLE (71335-1568-2) 42 capsule2016-05-19NoNoHistorical
71335-1568-37133515680330 CAPSULE in 1 BOTTLE (71335-1568-3) 30 capsule2016-05-19NoNoHistorical
71335-1568-47133515680460 CAPSULE in 1 BOTTLE (71335-1568-4) 60 capsule2016-05-19NoNoHistorical
71335-1568-57133515680590 CAPSULE in 1 BOTTLE (71335-1568-5) 90 capsule2016-05-19NoNoHistorical
71335-1568-67133515680614 CAPSULE in 1 BOTTLE (71335-1568-6) 14 capsule2016-05-19NoNoHistorical
71335-1568-77133515680720 CAPSULE in 1 BOTTLE (71335-1568-7) 20 capsule2016-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinBryant Ranch Prepack2025-03-28Human Prescription Drug Label4