FUZEON

Product NDC
0004-0381
11-digit product format
000040381
Labeler code
0004
Product ID
0004-0381_c73e3929-f256-4abf-b2a5-5bec18dadf71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enfuvirtide
Dosage form
KIT
Labeler
Genentech, Inc.
Application
NDA021481
Marketing category
NDA
Marketing start
2012-04-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0381-40EA - Each0004-03814b43b5f8-c0d3-41e1-a6e5-5111e0c42cac12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EnfuvirtideACTIVE INGREDIENT19OWO1T3ZEFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
EnfuvirtideACTIVE MOIETY19OWO1T3ZEFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
MannitolINACTIVE INGREDIENT3OWL53L36AFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
sodium carbonateINACTIVE INGREDIENT45P3261C7TFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13
WaterINACTIVE INGREDIENT059QF0KO0RFUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-0381FUZEON (ENFUVIRTIDE) KIT [GENENTECH, INC.]22Legacy NDC20221122_6935e846-d5a1-49e5-89a2-f8ebe4d5590d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0381-40000040381401 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE1 kit2012-04-100000-00-00NoNoCurrent