NDC 62935-754 - ELIGARD

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
62935-754
Package NDCs from labels
62935-754-74
Manufacturer
TOLMAR Inc.
Effective date
2019-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELIGARD - TOLMAR Inc.TOLMAR Inc.2019-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62935-754-74ELIGARD0.25 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED0.25 mL7.5 mg in 0.25mL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62935-754ELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR INC.]51Unmatched20240822_b78d1919-9dee-44fa-90f9-e0a26d32481d.zip

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VabrintyLEUPROLIDE ACETATEURONOVA PHARMACEUTICALS, INC.008776cc-83f1-4f8c-819b-6471425da15f2026-04-30Warnings, Adverse reactionsExact identifier
application number: NDA021731
application number: NDA021488
application number: NDA021343
application number: NDA021379
rxcui: 752899
rxcui: 752884
rxcui: 752889
rxcui: 752894
unii: 37JNS02E7V
EligardLEUPROLIDE ACETATETOLMAR Inc.b7b679a9-6823-4ef8-8d31-3ab5058ffcfc2026-04-30Warnings, Adverse reactionsExact identifier
application number: NDA021731
application number: NDA021488
application number: NDA021343
application number: NDA021379
rxcui: 752899
rxcui: 825333
rxcui: 825335
rxcui: 825325
rxcui: 752884
rxcui: 825334
rxcui: 752889
rxcui: 752894
unii: 37JNS02E7V
FensolviLEUPROLIDE ACETATETOLMAR Inc.2c311700-edf4-4f2a-a468-9875489a6cc72025-09-25Warnings, Adverse reactionsExact identifier
rxcui: 752884
unii: 37JNS02E7V
LEUPROLIDE ACETATELEUPROLIDE ACETATEEndo USA, Inc.290b0716-2fd5-43a1-8d3c-4857c1b2eefa2024-06-10Warnings, Adverse reactionsExact identifier
unii: 37JNS02E7V
FensolviLEUPROLIDE ACETATETOLMAR Inc.dfb6e01c-f138-471d-bf5b-2be38247e3f02022-04-28Warnings, Adverse reactionsExact identifier
rxcui: 752884
ELIGARDLEUPROLIDE ACETATETOLMAR Inc.b78d1919-9dee-44fa-90f9-e0a26d32481d2019-04-29Warnings, Adverse reactionsExact identifier
application number: NDA021731
application number: NDA021488
application number: NDA021343
application number: NDA021379
ndc (package): 62935-454-44
ndc (package): 62935-221-04
ndc (package): 62935-753-75
ndc (package): 62935-224-05
ndc (package): 62935-303-30
ndc (package): 62935-304-30
ndc (package): 62935-223-05
ndc (package): 62935-305-29
ndc (package): 62935-755-75
ndc (package): 62935-453-45
ndc (package): 62935-455-45
ndc (package): 62935-754-74
ndc (product): 62935-453
ndc (product): 62935-753
ndc (product): 62935-303
ndc (product): 62935-223
rxcui: 752899
rxcui: 825333
rxcui: 825335
rxcui: 825325
rxcui: 752884
rxcui: 825334
rxcui: 752889
rxcui: 752894
spl id: 2bea4c81-66a2-4817-9440-5f5da8dea04a
spl set id: b78d1919-9dee-44fa-90f9-e0a26d32481d