FDA.reportPublic FDA data

ibuprofen

Product NDC
59779-604
11-digit product format
597790604
Labeler code
59779
Product ID
59779-604_c61238a8-2d64-484b-84d9-6ad48a3c8526
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA072096
Marketing category
ANDA
Marketing start
2001-07-10
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
59779-604-00ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
59779-604-00ibuprofen2 in 1 PACKAGETABLET, FILM COATED214
59779-604-02ibuprofen550 in 1 BOTTLETABLET, FILM COATED55014
59779-604-47ibuprofen150 in 1 BOTTLETABLET, FILM COATED15014
59779-604-52ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-52ibuprofen10 in 1 BOTTLETABLET, FILM COATED1014
59779-604-59ibuprofen750 in 1 BOTTLETABLET, FILM COATED75014
59779-604-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414
59779-604-62ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
59779-604-71ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-72ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-72ibuprofen60 in 1 BOTTLETABLET, FILM COATED6014
59779-604-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED12014
59779-604-76ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-78ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
59779-604-82ibuprofen2 in 1 CARTONTABLET, FILM COATED214
59779-604-82ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
59779-604-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
59779-604-85ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-87ibuprofen300 in 1 BOTTLETABLET, FILM COATED30014
59779-604-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
59779-604-93ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-604-62EA - Each59779-604748f8d53-38b2-4155-9ddb-3bd30af6ab8512018-05-09
59779-604-82EA - Each59779-604345add93-8d0b-4205-ba8e-9c32bf9879ae12018-01-12
59779-604-90EA - Each59779-604c09abce4-fe8b-4afe-a2f1-464edbaf571312018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CVS PHARMACY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CVS PHARMACY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [CVS PHARMACY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [CVS PHARMACY]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET [CVS PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CVS PHARMACY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET [CVS PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [CVS PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [CVS PHARMACY]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [CVS PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-604IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]12Current NDC, Legacy NDC, 24 package rows20221229_ace493e6-91bc-41aa-8e5c-5bc14981de91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNace493e6-91bc-41aa-8e5c-5bc14981de9114
310965ibuprofen 200 MG Oral TabletSCDace493e6-91bc-41aa-8e5c-5bc14981de9114
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYace493e6-91bc-41aa-8e5c-5bc14981de9114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-604-00597790604002 BOTTLE in 1 PACKAGE (59779-604-00) / 500 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-04-15NoNoCurrent
59779-604-0259779060402550 TABLET, FILM COATED in 1 BOTTLE (59779-604-02) 2016-08-030000-00-00NoNoCurrent
59779-604-4759779060447150 TABLET, FILM COATED in 1 BOTTLE (59779-604-47) 2015-09-150000-00-00NoNoCurrent
59779-604-52597790604521 in 1 CARTONHistorical
59779-604-5959779060459750 in 1 BOTTLEHistorical
59779-604-62597790604621 BOTTLE in 1 CARTON (59779-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-71597790604711 BOTTLE in 1 CARTON (59779-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-72597790604721 in 1 CARTONHistorical
59779-604-76597790604761 BOTTLE in 1 CARTON (59779-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2003-03-110000-00-00NoNoCurrent
59779-604-78597790604781 BOTTLE in 1 CARTON (59779-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-82597790604822 BOTTLE in 1 CARTON (59779-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2010-03-030000-00-00NoNoCurrent
59779-604-8559779060485250 in 1 BOTTLEHistorical
59779-604-8759779060487300 TABLET, FILM COATED in 1 BOTTLE (59779-604-87) 2016-11-210000-00-00NoNoCurrent
59779-604-9059779060490500 TABLET, FILM COATED in 1 BOTTLE (59779-604-90) 2001-07-100000-00-00NoNoCurrent
59779-604-93597790604931000 TABLET, FILM COATED in 1 BOTTLE (59779-604-93) 2008-04-090000-00-00NoNoCurrent