FDA.reportPublic FDA data

Ganirelix Acetate

Product NDC
65219-028
11-digit product format
652190028
Labeler code
65219
Product ID
65219-028_8b68715d-8b5a-473f-90fb-453ba4267b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganirelix Acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA215658
Marketing category
ANDA
Marketing start
2023-03-24
Substance
GANIRELIX ACETATE
Active strength
250 ug/.5mL
Pharmacologic classes
Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ganirelix Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GANIRELIX ACETATE250 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56U7906FQW
Rxcui855200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1a687bc4-8d90-54b3-7bbb-399cd21f76f1Product name520260209
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-028-05Ganirelix Acetate1 mL in 1 SYRINGE, GLASSINJECTION12
65219-028-05Ganirelix Acetate1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-028-05ML - Milliliter65219-02804d9014a-1659-496f-84d3-f25feade161612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-028GANIRELIX ACETATE INJECTION [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20240530_c23ca7b2-7350-4f07-8adf-046bffb47842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855200ganirelix acetate 250 MCG in 0.5 ML Prefilled SyringePSNc23ca7b2-7350-4f07-8adf-046bffb478422
8552000.5 ML ganirelix acetate 0.5 MG/ML Prefilled SyringeSCDc23ca7b2-7350-4f07-8adf-046bffb478422
855200ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled SyringeSYc23ca7b2-7350-4f07-8adf-046bffb478422
855200ganirelix acetate 250 MCG per 0.5 ML Prefilled SyringeSYc23ca7b2-7350-4f07-8adf-046bffb478422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-028-05652190028051 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS2023-03-24NoNoCurrent