CHILDRENS IBUPROFEN

Product NDC
21130-216
11-digit product format
211300216
Labeler code
21130
Product ID
21130-216_3b217d19-5b93-40ef-a06d-471fb15b194c
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA209179
Marketing category
ANDA
Marketing start
2025-03-21
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
21130-216-20211300216201 BOTTLE in 1 CARTON (21130-216-20) / 240 mL in 1 BOTTLE1 bottle2025-03-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IBUPROFEN - Better Living Brands, LLC | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDBetter Living Brands, LLC | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-09-02Human OTC Drug Label3