Ibuprofen

Product NDC
59779-517
11-digit product format
597790517
Labeler code
59779
Product ID
59779-517_d759faf2-b385-41a2-8aaf-70bcc4a15748
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA077349
Marketing category
ANDA
Marketing start
2006-04-27
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
59779-517-71Ibuprofen50 in 1 BOTTLETABLET, FILM COATED506
59779-517-71Ibuprofen1 in 1 CARTONTABLET, FILM COATED16
59779-517-78Ibuprofen1 in 1 CARTONTABLET, FILM COATED16
59779-517-78Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-517-78EA - Each59779-5176c4b8808-84ad-4dff-88ba-99ce03161cbf12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
IRONINACTIVE INGREDIENTE1UOL152H7IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-517IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]5Current NDC, Legacy NDC, 4 package rows20231222_93f8101c-1cf7-4cb0-9c00-c57c9f9023c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN93f8101c-1cf7-4cb0-9c00-c57c9f9023c86
310965ibuprofen 200 MG Oral TabletSCD93f8101c-1cf7-4cb0-9c00-c57c9f9023c86
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY93f8101c-1cf7-4cb0-9c00-c57c9f9023c86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-517-71597790517711 BOTTLE in 1 CARTON (59779-517-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-04-270000-00-00NoNoCurrent
59779-517-78597790517781 BOTTLE in 1 CARTON (59779-517-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-04-270000-00-00NoNoCurrent