Indomethacin

Product NDC
70934-031
11-digit product format
709340031
Labeler code
70934
Product ID
70934-031_b7b0945c-4a18-0ef2-e053-2995a90a4fcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indomethacin
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA201807
Marketing category
ANDA
Marketing start
2017-03-13
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
75 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-031-142023-01-25C16284748780-1d6a99b39-e8cd-a426-e053-dadaa90af4c24aa335d1-1f22-72c8-e054-00144ff8d46c
70934-031-142022-01-28C16284748780-1d6a99b39-e8cd-a426-e053-dadaa90af4c24aa335d1-1f22-72c8-e054-00144ff8d46c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-031-14EA - Each70934-0313de8d5ba-13d0-4888-b1d5-e3ab1f06448712018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-031-147093400311414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70934-031-14) 2017-03-130000-00-00NoNoCurrent