FDA.reportPublic FDA data

Ibuprofen 200

Product NDC
0363-0393
11-digit product format
003630393
Labeler code
0363
Product ID
0363-0393_d6695f02-fda6-4dfa-a57f-19b50e264bcd
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen 200

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
0363-0393-12Ibuprofen 2001 in 1 CARTONTABLET, FILM COATED120
0363-0393-12Ibuprofen 200100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
0363-0393-14Ibuprofen 200500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020
0363-0393-15Ibuprofen 2001 in 1 CARTONTABLET, FILM COATED120
0363-0393-15Ibuprofen 20050 in 1 BOTTLE, PLASTICTABLET, FILM COATED5020
0363-0393-20Ibuprofen 200225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22520
0363-0393-37Ibuprofen 2001 in 1 CARTONTABLET, FILM COATED120
0363-0393-37Ibuprofen 20075 in 1 BOTTLE, PLASTICTABLET, FILM COATED7520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0393-08EA - Each0363-0393c2cb3d62-c52c-4ec5-b415-b3be961ae16012013-02-13
0363-0393-12EA - Each0363-0393194a97bb-dcb8-4423-bff5-ad71afa11f6312013-02-13
0363-0393-14EA - Each0363-03939443a7b3-899e-4b37-829c-0086c74c24f012013-02-13
0363-0393-15EA - Each0363-03933e522c35-949f-473e-89f3-0556dffab07212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN 200 (IBUPROFEN) TABLET, COATED [WALGREEN CO.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0393IBUPROFEN 200 (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]19Current NDC, Legacy NDC, 8 package rows20240704_62e8db95-aaef-4b0e-841e-64a0339f3190.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN62e8db95-aaef-4b0e-841e-64a0339f319020
310965ibuprofen 200 MG Oral TabletSCD62e8db95-aaef-4b0e-841e-64a0339f319020
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY62e8db95-aaef-4b0e-841e-64a0339f319020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0393-12003630393121 BOTTLE, PLASTIC in 1 CARTON (0363-0393-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-012023-04-07NoNoCurrent
0363-0393-1400363039314500 TABLET, COATED in 1 BOTTLE (0363-0393-14) 1999-03-010000-00-00NoNoCurrent
0363-0393-15003630393151 BOTTLE in 1 CARTON (0363-0393-15) > 50 TABLET, COATED in 1 BOTTLE1 bottle1999-03-012022-01-08NoNoCurrent
0363-0393-2000363039320225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0393-20) 1999-03-012026-10-31NoNoCurrent
0363-0393-37003630393371 in 1 CARTONHistorical