Fenoprofen

Product NDC
63629-5388
11-digit product format
636295388
Labeler code
63629
Product ID
63629-5388_f2e1b5fc-db48-4fa5-a933-9c12548c898d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA017604
Marketing category
NDA
Marketing start
2014-07-14
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5388-1EA - Each63629-53882cc50746-6bea-4cc6-8a3e-cf16a4ad874c12015-10-02
63629-5388-2EA - Each63629-53887ee09566-c325-4e23-a106-64a82e64182512015-10-02
63629-5388-3EA - Each63629-5388bd0d6066-ee72-4544-a9d9-34df3821491512015-10-02
63629-5388-4EA - Each63629-538859942e02-0afb-4d6b-9b88-87ea2415592a12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOPROFEN CALCIUMACTIVE INGREDIENT0X2CW1QABJFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
FENOPROFENACTIVE MOIETYRA33EAC7KYFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5388FENOPROFEN CAPSULE [BRYANT RANCH PREPACK]1000Legacy NDC20140912_e18dcccf-bcf2-45d4-b1fe-45729c926854.zip