FDA.reportPublic FDA data

Deslorelin Acetate

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC | LUMIS GLOBAL PHARMACEUTICALS CO LTD
Effective date
2013-11-01
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:50

Label at a glance#

ProductDeslorelin Acetate
Active ingredientDESLORELIN ACETATE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-7012-1Deslorelin Acetate1 g in 1 BOTTLEPOWDER11
58597-7012-2Deslorelin Acetate5 g in 1 BOTTLEPOWDER51
58597-7012-3Deslorelin Acetate10 g in 1 BOTTLEPOWDER101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-7012DESLORELIN ACETATE POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]13 package rows20131102_ac155b20-814b-405a-a8b2-ff4d5e92aaf4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DESLORELIN ACETATEACTIVE INGREDIENT679007NR5C1
DESLORELIN ACETATEACTIVE MOIETY679007NR5C1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-701258597-7012-1, 58597-7012-3, 58597-7012-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DESLORELIN ACETATE679007NR5CACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.