Ganirelix Acetate

Product NDC
0052-0301
11-digit product format
000520301
Labeler code
0052
Product ID
0052-0301_21680ef9-07e9-4350-8f1b-51232fc3f0e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganirelix Acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Organon USA Inc.
Application
NDA021057
Marketing category
NDA
Marketing start
1999-07-29
Marketing end
0000-00-00
Substance
GANIRELIX ACETATE
Active strength
250 ug/.5mL
Pharmacologic classes
Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
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
0052-0301-51ML - Milliliter0052-0301e8dd0993-bc05-41ed-b13e-de563b514d8b12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0052-0301-51000520301511 BLISTER PACK in 1 CARTON (0052-0301-51) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS1 blister pack1999-07-290000-00-00NoNoCurrent
0052-0301-81000520301811 BLISTER PACK in 1 CARTON (0052-0301-81) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS1 blister pack1999-07-290000-00-00NoNoCurrent