NDC 62935-305 - 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: 62935-305
Package NDCs from labels: 62935-305-29
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
Label	Manufacturer	Effective date	Type
ELIGARD - TOLMAR Inc.	TOLMAR Inc.	2019-04-29	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62935-305-29	ELIGARD	0.5 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	0.5 mL	30 mg in 0.5mL	51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62935-305	ELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR INC.]	51	Unmatched	20240822_b78d1919-9dee-44fa-90f9-e0a26d32481d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LEUPROLIDE ACETATE	ACTIVE INGREDIENT	37JNS02E7V	ELIGARD (LEUPROLIDE ACETATE) KIT [TOLMAR PHARMACEUTICALS INC.]	7
LEUPROLIDE	ACTIVE MOIETY	EFY6W0M8TG	ELIGARD (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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vabrinty	LEUPROLIDE ACETATE	URONOVA PHARMACEUTICALS, INC.	008776cc-83f1-4f8c-819b-6471425da15f	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: NDA021731 application number: NDA021488 application number: NDA021343 application number: NDA021379 rxcui: 752899 rxcui: 752884 rxcui: 752889 rxcui: 752894 unii: 37JNS02E7V
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Exact 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
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	2c311700-edf4-4f2a-a468-9875489a6cc7	2025-09-25	Warnings, Adverse reactions	Exact identifier rxcui: 752884 unii: 37JNS02E7V
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	Endo USA, Inc.	290b0716-2fd5-43a1-8d3c-4857c1b2eefa	2024-06-10	Warnings, Adverse reactions	Exact identifier unii: 37JNS02E7V
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Exact 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

Reported adverse events (FAERS/openFDA)#

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