FDA.reportPublic FDA data

ibuprofen

Product NDC
59779-313
11-digit product format
597790313
Labeler code
59779
Product ID
59779-313_b919ee53-a93c-40fc-8ab0-3f280f5ed9a9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075217
Marketing category
ANDA
Marketing start
2004-05-07
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442

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
59779-313-05ibuprofen1 in 1 CARTONSUSPENSION/ DROPS17
59779-313-05ibuprofen15 mL in 1 BOTTLESUSPENSION/ DROPS157
59779-313-10ibuprofen30 mL in 1 BOTTLESUSPENSION/ DROPS307
59779-313-10ibuprofen1 in 1 CARTONSUSPENSION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-313-10ML - Milliliter59779-313e2d5f7c2-3a5a-49ff-99f4-7230d877a7be12018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-313IBUPROFEN SUSPENSION/ DROPS [CVS PHARMACY]6Current NDC, Legacy NDC, 4 package rows20210611_e28d0916-8165-431c-a19c-ef7d4bb6b8e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNe28d0916-8165-431c-a19c-ef7d4bb6b8e67
204442ibuprofen 40 MG/ML Oral SuspensionSCDe28d0916-8165-431c-a19c-ef7d4bb6b8e67
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYe28d0916-8165-431c-a19c-ef7d4bb6b8e67
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYe28d0916-8165-431c-a19c-ef7d4bb6b8e67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-313-05597790313051 BOTTLE in 1 CARTON (59779-313-05) > 15 mL in 1 BOTTLE1 bottle2018-08-030000-00-00NoNoCurrent
59779-313-10597790313101 BOTTLE in 1 CARTON (59779-313-10) / 30 mL in 1 BOTTLE1 bottle2004-05-070000-00-00NoNoCurrent