NDC 62935-155 - Fensolvi

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
62935-155
Package NDCs from labels
62935-155-40
Manufacturer
TOLMAR Inc.
Effective date
2022-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fensolvi - TOLMAR Inc.TOLMAR Inc.2022-04-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62935-155FENSOLVI (LEUPROLIDE ACETATE) KIT [TOLMAR INC.]17Unmatched20231206_dfb6e01c-f138-471d-bf5b-2be38247e3f0.zip

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
rxcui: 752884
unii: 37JNS02E7V
EligardLEUPROLIDE ACETATETOLMAR Inc.b7b679a9-6823-4ef8-8d31-3ab5058ffcfc2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 752884
unii: 37JNS02E7V
FensolviLEUPROLIDE ACETATETOLMAR Inc.2c311700-edf4-4f2a-a468-9875489a6cc72025-09-25Warnings, Adverse reactionsExact identifier
application number: NDA213150
rxcui: 752884
rxcui: 2371773
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
application number: NDA213150
ndc (package): 62935-154-50
ndc (package): 62935-155-40
ndc (package): 62935-153-50
ndc (product): 62935-153
rxcui: 752884
rxcui: 2371773
spl id: eeda0531-099b-4b55-b287-8c534c3bb5f0
spl set id: dfb6e01c-f138-471d-bf5b-2be38247e3f0
ELIGARDLEUPROLIDE ACETATETOLMAR Inc.b78d1919-9dee-44fa-90f9-e0a26d32481d2019-04-29Warnings, Adverse reactionsExact identifier
rxcui: 752884