FDA.reportPublic FDA data

Eligard

Product NDC
62935-461
11-digit product format
629350461
Labeler code
62935
Product ID
62935-461_58cff066-4345-4624-8868-4c232a051a5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide acetate
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Labeler
TOLMAR Inc.
Application
NDA021731
Marketing category
NDA
Marketing start
2023-03-06
Substance
LEUPROLIDE ACETATE
Active strength
45 mg/.375mL
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEUPROLIDE ACETATE45 mg/.375mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii37JNS02E7V
Rxcui752884, 752889, 752894, 752899, 825325, 825333, 825334, 825335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62935-461-502024-01-30C16284748780-11030e365-0e14-111a-e063-dadaa90a10e20f03a91d-37eb-4e91-bf00-7fe097a4bead

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62935-461-50Eligard0.375 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.37519
62935-461-50Eligard1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62935-461ELIGARD (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]18Current NDC, 2 package rows20250228_b7b679a9-6823-4ef8-8d31-3ab5058ffcfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
825335Eligard 22.5 MG in 0.375 ML (3 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825333Eligard 30 MG in 0.5 ML (4 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825325Eligard 45 MG in 0.375 ML (6 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825334Eligard 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752894leuprolide acetate 22.5 MG in 0.375 mL (3 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752889leuprolide acetate 30 MG in 0.5 ML (4 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752884leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752899leuprolide acetate 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSNb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253340.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Eligard]SBDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253250.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Eligard]SBDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253350.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]SBDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253330.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]SBDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
7528990.25 ML leuprolide acetate 30 MG/ML Prefilled SyringeSCDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
7528840.375 ML leuprolide acetate 120 MG/ML Prefilled SyringeSCDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
7528940.375 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
7528890.5 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCDb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253340.25 ML Eligard 30 MG/ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253250.375 ML Eligard 120 MG/ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253350.375 ML Eligard 60 MG/ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
8253330.5 ML Eligard 60 MG/ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825335Eligard 22.5 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825333Eligard 30 MG per 0.5 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825325Eligard 45 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825334Eligard 7.5 MG per 0.25 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825335Eligard Every 3 Months 22.5 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825333Eligard Every 4 Months 30 MG per 0.5 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825325Eligard Every 6 Months 45 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
825334Eligard Monthly 7.5 MG per 0.25 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752894leuprolide acetate 22.5 MG per 0.375 ML (3 month) Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752894leuprolide acetate 22.5 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752889leuprolide acetate 30 MG per 0.5 ML (4 month) Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752884leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752884leuprolide acetate 45 MG per 0.375 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19
752899leuprolide acetate 7.5 MG per 0.25 ML Prefilled SyringeSYb7b679a9-6823-4ef8-8d31-3ab5058ffcfc19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62935-461-50629350461501 SYRINGE in 1 CARTON (62935-461-50) / .375 mL in 1 SYRINGE1 syringe2023-03-06NoNoCurrent