FDA.reportPublic FDA data

Ibuprofen

Product NDC
61715-167
11-digit product format
617150167
Labeler code
61715
Product ID
61715-167_0eec0d43-3b21-4150-901a-f520888aab22
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Kinray, Inc.
Application
ANDA091239
Marketing category
ANDA
Marketing start
2016-03-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-167-502025-06-03C16284748780-19d75b9d0-8b84-f424-e053-dadaa90a57ce6bc45351-5bb0-4b5e-ba1c-7b5149c5c0bc
61715-167-512025-06-03C16284748780-19d75b9d0-8b84-f424-e053-dadaa90a57ce6bc45351-5bb0-4b5e-ba1c-7b5149c5c0bc
61715-167-502020-01-31C16284748780-19d75b9d0-8b84-f424-e053-dadaa90a57ce6bc45351-5bb0-4b5e-ba1c-7b5149c5c0bc
61715-167-512020-01-31C16284748780-19d75b9d0-8b84-f424-e053-dadaa90a57ce6bc45351-5bb0-4b5e-ba1c-7b5149c5c0bc

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61715-167IBUPROFEN TABLET [KINRAY, INC.]1Legacy NDC20160301_6bc45351-5bb0-4b5e-ba1c-7b5149c5c0bc.zip