indomethacin

Product NDC
68382-294
11-digit product format
683820294
Labeler code
68382
Product ID
68382-294_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
50 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-294-01EA - Each68382-2943ef1dc22-b9d4-489f-bce1-6c1f5e379d9c12016-10-06
68382-294-05EA - Each68382-29461326aa9-14ec-44e8-81a5-5cffb5470f4412016-10-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-294-0168382029401100 CAPSULE in 1 BOTTLE (68382-294-01) 100 capsule2016-07-210000-00-00NoNoCurrent
68382-294-0568382029405500 CAPSULE in 1 BOTTLE (68382-294-05) 500 capsule2016-07-210000-00-00NoNoCurrent
68382-294-10683820294101000 CAPSULE in 1 BOTTLE (68382-294-10) 1000 capsule2016-07-210000-00-00NoNoCurrent
68382-294-306838202943010 CAPSULE in 1 BLISTER PACK (68382-294-30) 10 capsule2016-07-210000-00-00NoNoCurrent