Indomethacin

Product NDC
71205-822
11-digit product format
712050822
Labeler code
71205
Product ID
71205-822_0193c0a4-f595-609c-e063-6294a90aaa68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-822-307120508223030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-30) 2023-07-26NoNoHistorical
71205-822-607120508226060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-60) 2023-07-26NoNoHistorical
71205-822-907120508229090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-822-90) 2023-07-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Indomethacin Extended Release Capsules, USPProficient Rx LP2023-07-28HUMAN PRESCRIPTION DRUG LABEL2