CHILDRENS IBUPROFEN

Product NDC
79481-0419
11-digit product format
794810419
Labeler code
79481
Product ID
79481-0419_e515720d-be79-4de9-b2b8-73bcc4c80042
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA076359
Marketing category
ANDA
Marketing start
2025-06-30
Substance
IBUPROFEN
Active strength
100 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
79481-0419-0794810419001 BOTTLE in 1 CARTON (79481-0419-0) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2025-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Meijer Distribution, Inc. CHILDREN’S ibuprofen Drug FactsMeijer, Inc.2025-08-04HUMAN OTC DRUG LABEL2