FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS IBUPROFEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-8901-24CHILDRENS IBUPROFEN120 mL in 1 BOTTLESUSPENSION1203
0363-8901-24CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION13
0363-8901-37CHILDRENS IBUPROFEN2 in 1 CARTONSUSPENSION23
0363-8901-37CHILDRENS IBUPROFEN120 mL in 1 BOTTLESUSPENSION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8901CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [WALGREEN CO.]2Current NDC, 4 package rows20240113_fea3c4b2-cf96-2425-e053-6394a90ac697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNfea3c4b2-cf96-2425-e053-6394a90ac6973
197803ibuprofen 20 MG/ML Oral SuspensionSCDfea3c4b2-cf96-2425-e053-6394a90ac6973
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYfea3c4b2-cf96-2425-e053-6394a90ac6973
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYfea3c4b2-cf96-2425-e053-6394a90ac6973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-8901-24003638901241 BOTTLE in 1 CARTON (0363-8901-24) / 120 mL in 1 BOTTLE1 bottle2024-01-11NoNoCurrent
0363-8901-37003638901372 BOTTLE in 1 CARTON (0363-8901-37) / 120 mL in 1 BOTTLE2 bottle2024-01-11NoNoCurrent