Ibuprofen

Product NDC
68016-943
11-digit product format
680160943
Labeler code
68016
Product ID
68016-943_56338bc0-adfb-4188-9317-e8e8700faf93
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA074916
Marketing category
ANDA
Marketing start
2018-09-27
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-943IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]15Legacy NDC20250129_c90ad693-174f-4ef8-af01-0ddaebee8902.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-943-04680160943041 BOTTLE in 1 CARTON (68016-943-04) > 118 mL in 1 BOTTLE1 bottle2018-09-270000-00-00NoNoCurrent