FDA.reportPublic FDA data

ibuprofen

Product NDC
59779-647
11-digit product format
597790647
Labeler code
59779
Product ID
59779-647_86c7adc3-20a1-4477-91a4-9804feba6220
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA072096
Marketing category
ANDA
Marketing start
2001-07-31
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
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
59779-647-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED248
59779-647-62ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-71ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
59779-647-76ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
59779-647-78ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
59779-647-82ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-82ibuprofen200 in 1 BOTTLETABLET, FILM COATED2008
59779-647-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED2508
59779-647-85ibuprofen1 in 1 CARTONTABLET, FILM COATED18
59779-647-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008
59779-647-93ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008
59779-647-93ibuprofen2 in 1 PACKAGETABLET, FILM COATED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-647-62EA - Each59779-64771fe268f-84d3-40eb-8dfc-ec49b36501ae12018-12-13
59779-647-71EA - Each59779-6471ef36245-3ed2-4dbd-95c3-089d1b17cd8c12018-10-11
59779-647-78EA - Each59779-647f61503c9-1305-4dd5-acc2-90dbb1515bd012018-10-11

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-647IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]7Current NDC, Legacy NDC, 15 package rows20250112_e655bd64-dd82-46d8-87cc-2674beaffe20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe655bd64-dd82-46d8-87cc-2674beaffe208
310965ibuprofen 200 MG Oral TabletSCDe655bd64-dd82-46d8-87cc-2674beaffe208
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe655bd64-dd82-46d8-87cc-2674beaffe208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-647-62597790647621 BOTTLE in 1 CARTON (59779-647-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-647-71597790647711 BOTTLE in 1 CARTON (59779-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-647-76597790647761 in 1 CARTONHistorical
59779-647-78597790647781 BOTTLE in 1 CARTON (59779-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-08-020000-00-00NoNoCurrent
59779-647-82597790647821 BOTTLE in 1 CARTON (59779-647-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-080000-00-00NoNoCurrent
59779-647-8559779064785250 in 1 BOTTLEHistorical
59779-647-9059779064790500 TABLET, FILM COATED in 1 BOTTLE (59779-647-90) 2007-03-280000-00-00NoNoCurrent
59779-647-93597790647932 BOTTLE in 1 PACKAGE (59779-647-93) / 500 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-06-10NoNoHistorical