Indomethacin

Product NDC
63629-8993
11-digit product format
636298993
Labeler code
63629
Product ID
63629-8993_5274069c-1474-4285-b3f4-1217152a08c8
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
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
63629-8993-16362989930130 CAPSULE in 1 BOTTLE (63629-8993-1) 30 capsule2021-12-07NoNoHistorical
63629-8993-26362989930260 CAPSULE in 1 BOTTLE (63629-8993-2) 60 capsule2021-12-07NoNoHistorical
63629-8993-36362989930390 CAPSULE in 1 BOTTLE (63629-8993-3) 90 capsule2021-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IndomethacinBryant Ranch Prepack2025-03-27HUMAN PRESCRIPTION DRUG LABEL102