INDOMETHACIN

Product NDC
61919-526
11-digit product format
619190526
Labeler code
61919
Product ID
61919-526_151f8422-70b3-cf70-e063-6294a90a90fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
INDOMETHACIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091276
Marketing category
ANDA
Marketing start
2019-04-11
Substance
INDOMETHACIN
Active strength
25 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
61919-526-206191905262020 CAPSULE in 1 BOTTLE (61919-526-20) 20 capsule2019-04-11NoNoHistorical
61919-526-306191905263030 CAPSULE in 1 BOTTLE (61919-526-30) 30 capsule2019-04-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
INDOMETHACINDIRECT RX2024-04-02HUMAN PRESCRIPTION DRUG LABEL7