FDA.reportPublic FDA data

Ganirelix Acetate

Product NDC
78206-138
11-digit product format
782060138
Labeler code
78206
Product ID
78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganirelix Acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Organon LLC
Application
NDA021057
Marketing category
NDA
Marketing start
2021-06-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-138-01Ganirelix Acetate1 in 1 BLISTER PACKINJECTION, SOLUTION18
78206-138-01Ganirelix Acetate1 in 1 CARTONINJECTION, SOLUTION18
78206-138-02Ganirelix Acetate1 in 1 CARTONINJECTION, SOLUTION18
78206-138-02Ganirelix Acetate1 in 1 BLISTER PACKINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-138-01ML - Milliliter78206-138ee7365ec-0c2b-4db3-8349-a57cde402e8712021-10-08
78206-138-02ML - Milliliter78206-1387e379690-fe08-4c9f-bf70-3a4841d0b27d12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-138GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON LLC]7Current NDC, Legacy NDC, 4 package rows20240228_32fb74ff-993a-49fe-8943-e029372b863e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855200ganirelix acetate 250 MCG in 0.5 ML Prefilled SyringePSN32fb74ff-993a-49fe-8943-e029372b863e8
8552000.5 ML ganirelix acetate 0.5 MG/ML Prefilled SyringeSCD32fb74ff-993a-49fe-8943-e029372b863e8
855200ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled SyringeSY32fb74ff-993a-49fe-8943-e029372b863e8
855200ganirelix acetate 250 MCG per 0.5 ML Prefilled SyringeSY32fb74ff-993a-49fe-8943-e029372b863e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-138-01782060138011 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS1 blister pack2021-06-010000-00-00NoNoCurrent
78206-138-02782060138021 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS1 blister pack2024-02-16NoNoHistorical