FDA.reportPublic FDA data

Ganirelix Acetate

Product NDC
70700-327
11-digit product format
707000327
Labeler code
70700
Product ID
70700-327_4d50b641-9fb3-cb88-e063-6394a90a7b88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganirelix Acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Xiromed LLC
Application
ANDA215658
Marketing category
ANDA
Marketing start
2024-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ganirelix Acetate
Listing expiration
2027-12-31

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
70700-327-98Ganirelix Acetate1 mL in 1 SYRINGE, GLASSINJECTION12
70700-327-98Ganirelix Acetate1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-327-98ML - Milliliter70700-3279d2b2222-053f-44fd-a010-9a173779618d12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-327GANIRELIX ACETATE INJECTION [XIROMED LLC]1Current NDC, 2 package rows20240402_37a8e041-9751-665a-1965-765f7ff21922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855200ganirelix acetate 250 MCG in 0.5 ML Prefilled SyringePSN37a8e041-9751-665a-1965-765f7ff219222
8552000.5 ML ganirelix acetate 0.5 MG/ML Prefilled SyringeSCD37a8e041-9751-665a-1965-765f7ff219222
855200ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled SyringeSY37a8e041-9751-665a-1965-765f7ff219222
855200ganirelix acetate 250 MCG per 0.5 ML Prefilled SyringeSY37a8e041-9751-665a-1965-765f7ff219222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70700-327-98707000327981 SYRINGE, GLASS in 1 CARTON (70700-327-98) / 1 mL in 1 SYRINGE, GLASS2024-04-01NoNoHistorical