IBUPROFEN

Product NDC
0363-9601
11-digit product format
003639601
Labeler code
0363
Product ID
0363-9601_36e6a74f-1807-89de-e063-6394a90a01be
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
ANDA091239
Marketing category
ANDA
Marketing start
2018-12-11
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9601-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET10010
0363-9601-05IBUPROFEN50 in 1 BOTTLE, PLASTICTABLET5010
0363-9601-10IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET100010
0363-9601-15IBUPROFEN150 in 1 BOTTLE, PLASTICTABLET15010
0363-9601-20IBUPROFEN200 in 1 BOTTLE, PLASTICTABLET20010
0363-9601-42IBUPROFEN24 in 1 BOTTLE, PLASTICTABLET2410
0363-9601-50IBUPROFEN500 in 1 BOTTLE, PLASTICTABLET50010
0363-9601-97IBUPROFEN100 in 1 BOTTLETABLET10010
0363-9601-97IBUPROFEN2 in 1 CARTONTABLET210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9601IBUPROFEN TABLET [WALGREENS]9Current NDC, Legacy NDC, 9 package rows20240320_7653b33c-7489-10db-e053-2991aa0ab508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN7653b33c-7489-10db-e053-2991aa0ab50810
310965ibuprofen 200 MG Oral TabletSCD7653b33c-7489-10db-e053-2991aa0ab50810
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7653b33c-7489-10db-e053-2991aa0ab50810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9601-0100363960101100 TABLET in 1 BOTTLE, PLASTIC (0363-9601-01) 100 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-050036396010550 TABLET in 1 BOTTLE, PLASTIC (0363-9601-05) 50 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-10003639601101000 TABLET in 1 BOTTLE, PLASTIC (0363-9601-10) 1000 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-1500363960115150 TABLET in 1 BOTTLE, PLASTIC (0363-9601-15) 150 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-2000363960120200 TABLET in 1 BOTTLE, PLASTIC (0363-9601-20) 200 tablet2025-10-01NoNoCurrent
0363-9601-420036396014224 TABLET in 1 BOTTLE, PLASTIC (0363-9601-42) 24 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-5000363960150500 TABLET in 1 BOTTLE, PLASTIC (0363-9601-50) 500 tablet2018-12-110000-00-00NoNoCurrent
0363-9601-97003639601972 BOTTLE in 1 CARTON (0363-9601-97) / 100 TABLET in 1 BOTTLE2 bottle2018-12-110000-00-00NoNoCurrent