FDA.reportPublic FDA data

Ibuprofen

Product NDC
0363-0292
11-digit product format
003630292
Labeler code
0363
Product ID
0363-0292_07403884-9742-4920-9bae-c32d81417930
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
0363-0292-08Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2422
0363-0292-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
0363-0292-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10022
0363-0292-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
0363-0292-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50022
0363-0292-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5022
0363-0292-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
0363-0292-17Ibuprofen300 in 1 BOTTLETABLET, FILM COATED30022
0363-0292-37Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
0363-0292-37Ibuprofen75 in 1 BOTTLETABLET, FILM COATED7522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0292-08EA - Each0363-0292693556cf-ad0a-4adc-b2b4-7acbc3fb119012013-08-02
0363-0292-12EA - Each0363-02923d54af5d-6cb5-470a-8c3d-695dc7828ece12012-07-24
0363-0292-14EA - Each0363-02921c91466f-e855-482c-8303-249f0d6bc34912013-04-01
0363-0292-15EA - Each0363-0292e14c8cda-9ea0-4c35-b1cc-645512d3a2b512012-07-24
0363-0292-17EA - Each0363-029294019cb5-a7af-4e3c-9426-ad45658e103712024-04-05
0363-0292-37EA - Each0363-0292c727c797-fda9-4843-b3c7-e8e4be21d18712016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0292IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]21Current NDC, Legacy NDC, 10 package rows20250321_86818ad6-fd45-4635-9ce8-eac986f008aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN86818ad6-fd45-4635-9ce8-eac986f008aa22
310965ibuprofen 200 MG Oral TabletSCD86818ad6-fd45-4635-9ce8-eac986f008aa22
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY86818ad6-fd45-4635-9ce8-eac986f008aa22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0292-08003630292081 BOTTLE, PLASTIC in 1 CARTON (0363-0292-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
0363-0292-12003630292121 BOTTLE, PLASTIC in 1 CARTON (0363-0292-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242023-07-08NoNoCurrent
0363-0292-1400363029214500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0292-14) 1988-05-242023-07-07NoNoCurrent
0363-0292-15003630292151 BOTTLE, PLASTIC in 1 CARTON (0363-0292-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
0363-0292-1700363029217300 TABLET, FILM COATED in 1 BOTTLE (0363-0292-17) 1988-05-242023-06-01NoNoCurrent
0363-0292-37003630292371 in 1 CARTONHistorical