NDC 68196-291

Ibuprofen

Ibuprofen

Ibuprofen is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Sam's West Inc. The primary component is Ibuprofen.

Product ID68196-291_98bec458-1241-4988-92f4-85588eb10278
NDC68196-291
Product TypeHuman Otc Drug
Proprietary NameIbuprofen
Generic NameIbuprofen
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1988-05-24
Marketing CategoryANDA /
Application NumberANDA075010
Labeler NameSam's West Inc
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68196-291-78

600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-291-78)
Marketing Start Date1988-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68196-291-14 [68196029114]

Ibuprofen TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date1988-05-24
Marketing End Date2016-10-22

Drug Details

NDC Crossover Matching brand name "Ibuprofen" or generic name "Ibuprofen"

NDCBrand NameGeneric Name
67877-120ibuprofenibuprofen
67877-119ibuprofenibuprofen
67877-295ibuprofenibuprofen
67877-121ibuprofenibuprofen
67877-294ibuprofenibuprofen
67877-296ibuprofenibuprofen
67877-321IbuprofenIbuprofen
67877-319IbuprofenIbuprofen
67877-320IbuprofenIbuprofen
68016-116IbuprofenIbuprofen
68016-633IbuprofenIbuprofen
68016-626IbuprofenIbuprofen
68016-634IbuprofenIbuprofen
68016-645IbuprofenIbuprofen
68016-295IbuprofenIbuprofen
68016-635IbuprofenIbuprofen
68071-3074IbuprofenIbuprofen
68071-3362IBUPROFENIBUPROFEN
68071-4129IbuprofenIbuprofen
68071-4009IBUPROFENIBUPROFEN
68071-3388IbuprofenIbuprofen
68071-4253IbuprofenIbuprofen
68071-4306IbuprofenIbuprofen
68071-4357IbuprofenIbuprofen
68071-4563IbuprofenIbuprofen
68071-4280IbuprofenIbuprofen
68071-4243IBUPROFENIBUPROFEN
68071-4820IbuprofenIbuprofen
68071-4305IbuprofenIbuprofen
68071-4459IBUPROFENIBUPROFEN
68084-703IbuprofenIbuprofen
68084-658IbuprofenIbuprofen
68084-772IbuprofenIbuprofen
68196-980IbuprofenIbuprofen
68196-981IbuprofenIbuprofen
68210-0200IBUPROFENIBUPROFEN
68196-199IbuprofenIbuprofen
68210-0009IBUPROFENIBUPROFEN
68196-745IbuprofenIbuprofen
68387-208IbuprofenIbuprofen
0472-2002IbuprofenIbuprofen
68387-210IbuprofenIbuprofen
68391-121IbuprofenIbuprofen
68391-199IbuprofenIbuprofen
0472-1270IbuprofenIbuprofen
68645-531IbuprofenIbuprofen
68645-563IbuprofenIbuprofen
68645-562IbuprofenIbuprofen
68645-561IbuprofenIbuprofen
0113-1461basic care childrens ibuprofenIbuprofen

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.