Topcare Ibuprofen

Product NDC
36800-074
11-digit product format
368000074
Labeler code
36800
Product ID
36800-074_c2b22cd7-e373-4773-97ad-3108ef71be01
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2006-04-10
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 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
36800-074-71EA - Each36800-074c8ec80aa-eb56-411f-9270-a0affd5564de12012-07-24
36800-074-78EA - Each36800-07425e08e7a-93fc-487c-abbc-e4365d2eda4312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-074-71368000074711 BOTTLE in 1 CARTON (36800-074-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-04-100000-00-00NoNoCurrent
36800-074-78368000074781 BOTTLE in 1 CARTON (36800-074-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-06-130000-00-00NoNoCurrent