FDA.reportPublic FDA data

ibuprofen

Product NDC
0363-0604
11-digit product format
003630604
Labeler code
0363
Product ID
0363-0604_8c0ff9e7-6d01-4bab-b0ca-7779c10d9b77
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
2009-01-21
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
0363-0604-52ibuprofen10 in 1 BOTTLETABLET, FILM COATED108
0363-0604-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED248
0363-0604-62ibuprofen1 in 1 CARTONTABLET, FILM COATED18
0363-0604-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
0363-0604-71ibuprofen1 in 1 CARTONTABLET, FILM COATED18
0363-0604-76ibuprofen1 in 1 CARTONTABLET, FILM COATED18
0363-0604-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
0363-0604-78ibuprofen1 in 1 CARTONTABLET, FILM COATED18
0363-0604-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
0363-0604-82ibuprofen2 in 1 CARTONTABLET, FILM COATED28
0363-0604-82ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0604-52EA - Each0363-0604d82a3d76-2299-4252-87ff-b1663ec1da2912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0604IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]7Current NDC, Legacy NDC, 11 package rows20241215_37c9b887-190a-4daf-8199-f406913132f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN37c9b887-190a-4daf-8199-f406913132f08
310965ibuprofen 200 MG Oral TabletSCD37c9b887-190a-4daf-8199-f406913132f08
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY37c9b887-190a-4daf-8199-f406913132f08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0604-520036306045210 in 1 BOTTLEHistorical
0363-0604-62003630604621 BOTTLE in 1 CARTON (0363-0604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-090000-00-00NoNoCurrent
0363-0604-71003630604711 BOTTLE in 1 CARTON (0363-0604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-090000-00-00NoNoCurrent
0363-0604-76003630604761 BOTTLE in 1 CARTON (0363-0604-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-12-13NoNoCurrent
0363-0604-78003630604781 BOTTLE in 1 CARTON (0363-0604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-290000-00-00NoNoCurrent
0363-0604-82003630604822 BOTTLE in 1 CARTON (0363-0604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2024-01-19NoNoCurrent