FDA.reportPublic FDA data

ELIGARD

Product NDC
62935-223
11-digit product format
629350223
Labeler code
62935
Product ID
62935-223_2bea4c81-66a2-4817-9440-5f5da8dea04a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leuprolide Acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
TOLMAR Inc.
Application
NDA021379
Marketing category
NDA
Marketing start
2002-08-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELIGARD
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62935-221-04ELIGARD0.375 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.375 mL22.5 mg in 0.375mL51
62935-223-05ELIGARD1 in 1 CARTONKIT151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62935-223-05EA - Each62935-223f2279ca4-9b61-4edb-8850-cda380ecf51012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEUPROLIDE ACETATEACTIVE INGREDIENT37JNS02E7VELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR PHARMACEUTICALS INC.]7
LEUPROLIDEACTIVE MOIETYEFY6W0M8TGELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62935-223ELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR INC.]51Current NDC, Legacy NDC, 2 package rows20240822_b78d1919-9dee-44fa-90f9-e0a26d32481d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
825335Eligard 22.5 MG in 0.375 ML (3 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
825333Eligard 30 MG in 0.5 ML (4 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
825325Eligard 45 MG in 0.375 ML (6 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
825334Eligard 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
752894leuprolide acetate 22.5 MG in 0.375 mL (3 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
752889leuprolide acetate 30 MG in 0.5 ML (4 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
752884leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
752899leuprolide acetate 7.5 MG in 0.25 ML (1 month) Prefilled SyringePSNb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253340.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Eligard]SBDb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253250.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Eligard]SBDb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253350.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]SBDb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253330.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]SBDb78d1919-9dee-44fa-90f9-e0a26d32481d51
7528990.25 ML leuprolide acetate 30 MG/ML Prefilled SyringeSCDb78d1919-9dee-44fa-90f9-e0a26d32481d51
7528840.375 ML leuprolide acetate 120 MG/ML Prefilled SyringeSCDb78d1919-9dee-44fa-90f9-e0a26d32481d51
7528940.375 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCDb78d1919-9dee-44fa-90f9-e0a26d32481d51
7528890.5 ML leuprolide acetate 60 MG/ML Prefilled SyringeSCDb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253340.25 ML Eligard 30 MG/ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253250.375 ML Eligard 120 MG/ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253350.375 ML Eligard 60 MG/ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
8253330.5 ML Eligard 60 MG/ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825335Eligard 22.5 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825333Eligard 30 MG per 0.5 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825325Eligard 45 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825334Eligard 7.5 MG per 0.25 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825335Eligard Every 3 Months 22.5 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825333Eligard Every 4 Months 30 MG per 0.5 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825325Eligard Every 6 Months 45 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
825334Eligard Monthly 7.5 MG per 0.25 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752894leuprolide acetate 22.5 MG per 0.375 ML (3 month) Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752894leuprolide acetate 22.5 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752889leuprolide acetate 30 MG per 0.5 ML (4 month) Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752884leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752884leuprolide acetate 45 MG per 0.375 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51
752899leuprolide acetate 7.5 MG per 0.25 ML Prefilled SyringeSYb78d1919-9dee-44fa-90f9-e0a26d32481d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62935-221-04629350221040.375 mL in 1 SYRINGE0.375 mlHistorical
62935-223-05629350223051 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05) 1 kit2002-08-260000-00-00NoNoCurrent