CHILDRENS IBUPROFEN

Product NDC
68001-521
11-digit product format
680010521
Labeler code
68001
Product ID
68001-521_fcff74f6-9432-d82c-e053-6394a90a8cfe
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA209179
Marketing category
ANDA
Marketing start
2022-09-12
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
68001-521-92680010521921 BOTTLE in 1 CARTON (68001-521-92) / 120 mL in 1 BOTTLE1 bottle2022-09-12NoNoHistorical
68001-521-94680010521941 BOTTLE in 1 CARTON (68001-521-94) / 240 mL in 1 BOTTLE1 bottle2023-05-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CHILDRENS IBUPROFEN - BluePoint Laboratories | Aurobindo Pharma LimitedBluePoint Laboratories | Aurobindo Pharma Limited2023-05-31HUMAN OTC DRUG LABEL2