indomethacin

Product NDC
68382-293
11-digit product format
683820293
Labeler code
68382
Product ID
68382-293_22e405cf-6720-4017-bdd1-1b2c25e81f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA090403
Marketing category
ANDA
Marketing start
2016-07-21
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
25 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-293-01EA - Each68382-29327d3775b-f8ac-4559-ab69-45b2e54af11912016-10-06
68382-293-10EA - Each68382-2935b200148-6ff3-4675-a908-34654fb814cc12016-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197817indomethacin 25 MG Oral CapsulePSN50d853fa-cdaa-488a-e054-00144ff88e883
197817indomethacin 25 MG Oral CapsuleSCD50d853fa-cdaa-488a-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-293-0168382029301100 CAPSULE in 1 BOTTLE (68382-293-01) 100 capsule2016-07-210000-00-00NoNoCurrent
68382-293-0568382029305500 CAPSULE in 1 BOTTLE (68382-293-05) 500 capsule2016-07-210000-00-00NoNoCurrent
68382-293-10683820293101000 CAPSULE in 1 BOTTLE (68382-293-10) 1000 capsule2016-07-210000-00-00NoNoCurrent
68382-293-306838202933010 CAPSULE in 1 BLISTER PACK (68382-293-30) 10 capsule2016-07-210000-00-00NoNoCurrent