FDA.reportPublic FDA data

IBUPROFEN

Product NDC
0363-9594
11-digit product format
003639594
Labeler code
0363
Product ID
0363-9594_46531382-aeef-ad11-e063-6294a90a81f4
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS CO.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2021-10-15
Substance
IBUPROFEN
Active strength
200 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
0363-9594-07IBUPROFEN15 in 1 BOTTLETABLET157
0363-9594-10IBUPROFEN100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9594IBUPROFEN TABLET [WALGREENS CO.]6Current NDC, Legacy NDC, 2 package rows20241218_b8a77b7e-e161-b3ac-e053-2995a90af3e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNb8a77b7e-e161-b3ac-e053-2995a90af3e87
310965ibuprofen 200 MG Oral TabletSCDb8a77b7e-e161-b3ac-e053-2995a90af3e87
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYb8a77b7e-e161-b3ac-e053-2995a90af3e87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9594-070036395940715 TABLET in 1 BOTTLE (0363-9594-07) 15 tablet2023-09-01NoNoHistorical
0363-9594-1000363959410100 TABLET in 1 BOTTLE (0363-9594-10) 100 tablet2021-10-150000-00-00NoNoCurrent