Ibuprofen

Product NDC
55319-136
11-digit product format
553190136
Labeler code
55319
Product ID
55319-136_ea710bfa-eee3-4284-9b18-2533771276e6
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
ANDA079129
Marketing category
ANDA
Marketing start
2023-08-31
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-136-0555319013605500 TABLET, COATED in 1 BOTTLE, PLASTIC (55319-136-05) 2023-08-31NoNoHistorical
55319-136-24553190136241 BOTTLE, PLASTIC in 1 BOX (55319-136-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-08-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsFamily Dollar (FAMILY WELLNESS)2023-06-22HUMAN OTC DRUG LABEL3