FDA.reportPublic FDA data

Ibuprofen

Product NDC
0363-0291
11-digit product format
003630291
Labeler code
0363
Product ID
0363-0291_93d5e52b-b346-422b-b801-25ce2a20888b
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
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
0363-0291-03Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1020
0363-0291-08Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2420
0363-0291-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED120
0363-0291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
0363-0291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED120
0363-0291-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
0363-0291-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED120
0363-0291-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5020
0363-0291-16Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100020
0363-0291-29Ibuprofen150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15020
0363-0291-37Ibuprofen1 in 1 CARTONTABLET, FILM COATED120
0363-0291-37Ibuprofen75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7520
0363-0291-57Ibuprofen1 in 1 CARTONTABLET, FILM COATED120
0363-0291-57Ibuprofen125 in 1 BOTTLE, PLASTICTABLET, FILM COATED12520
0363-0291-99Ibuprofen2 in 1 CARTONTABLET, FILM COATED220
0363-0291-99Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0291-08EA - Each0363-0291c8f77c41-81d7-4687-8490-60626156868612018-09-05
0363-0291-12EA - Each0363-029134d18329-2f9d-4a22-974d-1e62da0c4a6612013-02-13
0363-0291-14EA - Each0363-029113650cc4-0889-4780-94b0-9a7a3cf3ce1c12022-06-06
0363-0291-15EA - Each0363-02910a8eb253-1bc6-48c8-b751-645c88849f4412013-02-13
0363-0291-16EA - Each0363-02916d28cb57-c391-44df-bb19-75ac5d62240312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [WALGREEN CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0291IBUPROFEN TABLET, FILM COATED [WALGREEN COMPANY]18Current NDC, Legacy NDC, 16 package rows20240823_c118b290-f821-4e73-906e-8a93edaf34e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNc118b290-f821-4e73-906e-8a93edaf34e420
310965ibuprofen 200 MG Oral TabletSCDc118b290-f821-4e73-906e-8a93edaf34e420
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc118b290-f821-4e73-906e-8a93edaf34e420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0291-030036302910310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-03) 1988-05-240000-00-00NoNoCurrent
0363-0291-08003630291081 BOTTLE, PLASTIC in 1 CARTON (0363-0291-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
0363-0291-12003630291121 BOTTLE, PLASTIC in 1 CARTON (0363-0291-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
0363-0291-1400363029114500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-14) 1998-05-240000-00-00NoNoCurrent
0363-0291-15003630291151 BOTTLE, PLASTIC in 1 CARTON (0363-0291-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
0363-0291-16003630291161000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-16) 2023-05-25NoNoHistorical
0363-0291-2900363029129150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-29) 1988-05-240000-00-00NoNoCurrent
0363-0291-37003630291371 in 1 CARTONHistorical
0363-0291-57003630291571 in 1 CARTONHistorical
0363-0291-99003630291992 BOTTLE, PLASTIC in 1 CARTON (0363-0291-99) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent