CHILDRENS IBUPROFEN

Product NDC
0363-8901
11-digit product format
003638901
Labeler code
0363
Product ID
0363-8901_f3fc1688-5031-4909-85e3-066820f29f2a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA209179
Marketing category
ANDA
Marketing start
2024-01-11
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
0363-8901-24003638901241 BOTTLE in 1 CARTON (0363-8901-24) / 120 mL in 1 BOTTLE1 bottle2024-01-11NoNoHistorical
0363-8901-37003638901372 BOTTLE in 1 CARTON (0363-8901-37) / 120 mL in 1 BOTTLE2 bottle2024-01-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CHILDRENS IBUPROFEN - WALGREEN CO. | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDWALGREEN CO. | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-09-02Human OTC Drug Label3