Ibuprofen

Product NDC
55910-399
11-digit product format
559100399
Labeler code
55910
Product ID
55910-399_e177a580-dbcd-6a37-e053-2995a90a6fb8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DOLGENCORP, INC.
Application
ANDA079205
Marketing category
ANDA
Marketing start
2022-07-12
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-399-1255910039912120 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-399-12) 2022-07-12NoNoHistorical
55910-399-2055910039920200 CAPSULE, LIQUID FILLED in 1 BOTTLE (55910-399-20) 2022-07-12NoNoHistorical
55910-399-23559100399231 BOTTLE in 1 CARTON (55910-399-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-07-12NoNoHistorical
55910-399-80559100399801 BOTTLE in 1 CARTON (55910-399-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-07-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
610T Dollar General 55910-399 Ibuprofen Capsules 200 mgDOLGENCORP, INC. | TIME CAP LABORATORIES, INC. | Marksans Pharma Ltd2022-07-07HUMAN OTC DRUG LABEL2