Ibuprofen

Product NDC
59779-685
11-digit product format
597790685
Labeler code
59779
Product ID
59779-685_66ee2954-8ef4-4b54-bd50-665e4874b387
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA074937
Marketing category
ANDA
Marketing start
2009-06-30
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
59779-685-26Ibuprofen120 mL in 1 BOTTLESUSPENSION1208
59779-685-26Ibuprofen1 in 1 CARTONSUSPENSION18
59779-685-28Ibuprofen1 in 1 CARTONSUSPENSION18
59779-685-28Ibuprofen150 mL in 1 BOTTLESUSPENSION1508
59779-685-34Ibuprofen1 in 1 CARTONSUSPENSION18
59779-685-34Ibuprofen240 mL in 1 BOTTLESUSPENSION2408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-685-26ML - Milliliter59779-6854b57885c-22e2-42a0-9d80-bc18a5652d1612019-11-12
59779-685-34ML - Milliliter59779-68517d0a2da-121f-455e-a0d1-2886877dc75712019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN LIQUID [CVS PHARMACY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN LIQUID [CVS PHARMACY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN LIQUID [CVS PHARMACY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN LIQUID [CVS PHARMACY]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SIBUPROFEN LIQUID [CVS PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN LIQUID [CVS PHARMACY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN LIQUID [CVS PHARMACY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN LIQUID [CVS PHARMACY]2
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN LIQUID [CVS PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN LIQUID [CVS PHARMACY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN LIQUID [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-685IBUPROFEN SUSPENSION [CVS PHARMACY]7Current NDC, Legacy NDC, 6 package rows20250420_ef204cc0-4009-4dd0-83e2-2b5ad6f98409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNef204cc0-4009-4dd0-83e2-2b5ad6f984098
197803ibuprofen 20 MG/ML Oral SuspensionSCDef204cc0-4009-4dd0-83e2-2b5ad6f984098
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYef204cc0-4009-4dd0-83e2-2b5ad6f984098
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYef204cc0-4009-4dd0-83e2-2b5ad6f984098

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-685-26597790685261 BOTTLE in 1 CARTON (59779-685-26) / 120 mL in 1 BOTTLE1 bottle2009-06-300000-00-00NoNoCurrent
59779-685-28597790685281 BOTTLE in 1 CARTON (59779-685-28) > 150 mL in 1 BOTTLE1 bottle2018-03-130000-00-00NoNoCurrent
59779-685-34597790685341 BOTTLE in 1 CARTON (59779-685-34) / 240 mL in 1 BOTTLE1 bottle2019-04-220000-00-00NoNoCurrent