Indomethacin

Product NDC
35356-697
11-digit product format
353560697
Labeler code
35356
Product ID
35356-697_286c4f19-4b7a-4232-ba80-eb45a6bbbd71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA091276
Marketing category
ANDA
Marketing start
2010-12-22
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
50 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-697-15EA - Each35356-697c0505d61-3472-487f-9e6d-93db85af1ab712015-10-02
35356-697-21EA - Each35356-697e1ce137f-7c8b-480f-b87d-0a523e3023e912012-07-24
35356-697-30EA - Each35356-6975d81f648-25b5-44c4-8aad-8f107ea1ff8012018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-697-153535606971515 CAPSULE in 1 BOTTLE (35356-697-15) 15 capsule2010-12-220000-00-00NoNoCurrent
35356-697-303535606973030 CAPSULE in 1 BOTTLE (35356-697-30) 30 capsule2010-12-220000-00-00NoNoCurrent