Ibuprofen

Product NDC
68788-8201
11-digit product format
687888201
Labeler code
68788
Product ID
68788-8201_44842e31-504a-4ab8-9f62-f188f89b9061
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA071268
Marketing category
ANDA
Marketing start
2022-05-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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
68788-8201-1EA - Each68788-82013336060a-8bb0-4a98-b863-499dcffed6fd12022-07-06
68788-8201-2EA - Each68788-8201c8b0d193-5729-4b89-8501-a35f50dc43ea12022-07-06
68788-8201-3EA - Each68788-8201f3ccfe7f-a5a7-47d3-9641-907766b85ead12022-07-06
68788-8201-5EA - Each68788-8201d677e92a-4bcc-4735-8563-38248a7e456d12022-07-06
68788-8201-6EA - Each68788-82016d725303-ba96-4adc-af31-18204aa4806212022-07-06
68788-8201-8EA - Each68788-820177576c7d-1635-41f1-8683-ceb991c8397712022-08-04
68788-8201-9EA - Each68788-820111d52240-0929-413e-844f-936fde1f137a12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8201IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240526_44842e31-504a-4ab8-9f62-f188f89b9061.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8201-168788820101100 TABLET, FILM COATED in 1 BOTTLE (68788-8201-1) 2022-05-230000-00-00NoNoCurrent
68788-8201-26878882010220 TABLET, FILM COATED in 1 BOTTLE (68788-8201-2) 2022-05-230000-00-00NoNoCurrent
68788-8201-36878882010330 TABLET, FILM COATED in 1 BOTTLE (68788-8201-3) 2022-05-230000-00-00NoNoCurrent
68788-8201-56878882010550 TABLET, FILM COATED in 1 BOTTLE (68788-8201-5) 2022-05-230000-00-00NoNoCurrent
68788-8201-66878882010660 TABLET, FILM COATED in 1 BOTTLE (68788-8201-6) 2022-05-230000-00-00NoNoCurrent
68788-8201-86878882010828 TABLET, FILM COATED in 1 BOTTLE (68788-8201-8) 2022-05-230000-00-00NoNoCurrent
68788-8201-96878882010990 TABLET, FILM COATED in 1 BOTTLE (68788-8201-9) 2022-05-230000-00-00NoNoCurrent