Ibuprofen

Product NDC
68788-8244
11-digit product format
687888244
Labeler code
68788
Product ID
68788-8244_b751b074-fade-4e69-a750-f4aeb42805dd
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
2022-08-09
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
68788-8244-1EA - Each68788-82449140c01a-9f0e-46b6-89b0-294548b15da612022-09-12
68788-8244-2EA - Each68788-82447d994800-c96f-4dcc-9487-c511ea2c6c3312022-09-12
68788-8244-3EA - Each68788-82443ad08b99-3526-4ae5-9a5a-8682361b590512022-09-12
68788-8244-4EA - Each68788-8244535f8ced-3767-4695-b9f3-3dcd5223f7bd12022-09-12
68788-8244-5EA - Each68788-8244ecfd1eda-a072-40fe-b511-19da7b8bbacf12022-09-12
68788-8244-6EA - Each68788-82449976e2f3-e607-45e4-a70f-d54d774dffd112022-09-12
68788-8244-7EA - Each68788-824405c30f13-957c-40ae-91bf-91a85d8549ed12022-09-12
68788-8244-8EA - Each68788-82440451f54f-66d3-46c5-8dea-e6aae91bc83c12022-09-12
68788-8244-9EA - Each68788-824453198b65-b092-4272-b030-7f3b16faede712022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8244IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240526_b751b074-fade-4e69-a750-f4aeb42805dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8244-168788824401100 TABLET, FILM COATED in 1 BOTTLE (68788-8244-1) 2022-08-090000-00-00NoNoCurrent
68788-8244-26878882440220 TABLET, FILM COATED in 1 BOTTLE (68788-8244-2) 2022-08-090000-00-00NoNoCurrent
68788-8244-36878882440330 TABLET, FILM COATED in 1 BOTTLE (68788-8244-3) 2022-08-090000-00-00NoNoCurrent
68788-8244-46878882440414 TABLET, FILM COATED in 1 BOTTLE (68788-8244-4) 2022-08-090000-00-00NoNoCurrent
68788-8244-56878882440550 TABLET, FILM COATED in 1 BOTTLE (68788-8244-5) 2022-08-090000-00-00NoNoCurrent
68788-8244-66878882440660 TABLET, FILM COATED in 1 BOTTLE (68788-8244-6) 2022-08-090000-00-00NoNoCurrent
68788-8244-76878882440721 TABLET, FILM COATED in 1 BOTTLE (68788-8244-7) 2022-08-090000-00-00NoNoCurrent
68788-8244-868788824408120 TABLET, FILM COATED in 1 BOTTLE (68788-8244-8) 2022-08-090000-00-00NoNoCurrent
68788-8244-96878882440990 TABLET, FILM COATED in 1 BOTTLE (68788-8244-9) 2022-08-090000-00-00NoNoCurrent