Ibuprofen

Product NDC
45802-057
11-digit product format
458020057
Labeler code
45802
Product ID
45802-057_195eac27-a311-4d14-9764-18e3ed73ee9d
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA075217
Marketing category
ANDA
Marketing start
2014-04-09
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-057-05ML - Milliliter45802-057e9e7dc11-5938-4602-99aa-ed0e7ecb5a9212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-057IBUPROFEN SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Legacy NDC20250213_49924f8e-7dff-425f-b5dc-9d379e052ea3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-057-05458020057051 BOTTLE in 1 CARTON (45802-057-05) > 15 mL in 1 BOTTLE1 bottle2014-04-090000-00-00NoNoCurrent