FDA.reportPublic FDA data

SUPPRELIN

Product NDC
67979-002
11-digit product format
679790002
Labeler code
67979
Product ID
67979-002_917e915f-4793-48bf-84c3-50272421616f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
histrelin acetate
Dosage form
IMPLANT
Route
SUBCUTANEOUS
Labeler
Endo USA, Inc.
Application
NDA022058
Marketing category
NDA
Marketing start
2007-05-31
Substance
HISTRELIN ACETATE
Active strength
50 mg/1
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUPPRELIN
Brand name suffix
LA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTRELIN ACETATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQMG7HLD1ZE
Rxcui1294641, 1740437

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77e9eb99-9c92-7584-f2ea-26b00d25ea66Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67979-002-01SUPPRELINLA1 in 1 VIAL, GLASSIMPLANT138
67979-002-01SUPPRELINLA1 in 1 CARTONIMPLANT138

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67979-002-01EA - Each67979-002599fb662-151c-4eeb-9814-6a0f6540357c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HISTRELIN ACETATEACTIVE INGREDIENTQMG7HLD1ZESUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
HISTRELINACTIVE MOIETYH50H3S3W74SUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
2-HYDROXYETHYL METHACRYLATEINACTIVE INGREDIENT6E1I4IV47VSUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
DI-(4-TERT-BUTYLCYCLOHEXYL)PEROXYDICARBONATEINACTIVE INGREDIENT076NU497LZSUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
METHYL BENZOININACTIVE INGREDIENTXIF870BGWWSUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSSUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO PHARMACEUTICALS SOLUTIONS INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67979-002SUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO USA, INC.]36Current NDC, Legacy NDC, 2 package rows20240425_d8fb000e-3cc9-4803-b71d-2cc597661977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740437histrelin acetate 50 MG (65 MCG per 24HR) Subcutaneous Drug ImplantPSNd8fb000e-3cc9-4803-b71d-2cc59766197738
1294641Supprelin LA 50 MG (65 MCG per 24HR) Subcutaneous Drug ImplantPSNd8fb000e-3cc9-4803-b71d-2cc59766197738
1294641histrelin acetate 0.00271 MG/HR Drug Implant [Supprelin]SBDd8fb000e-3cc9-4803-b71d-2cc59766197738
1740437histrelin acetate 0.00271 MG/HR Drug ImplantSCDd8fb000e-3cc9-4803-b71d-2cc59766197738
1740437histrelin acetate 50 MG (65 MCG per 24 HR) Drug ImplantSYd8fb000e-3cc9-4803-b71d-2cc59766197738
1294641Supprelin 50 MG (65 MCG per 24 HR) Drug ImplantSYd8fb000e-3cc9-4803-b71d-2cc59766197738

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67979-002-01679790002011 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS2007-05-310000-00-00NoNoCurrent