FDA.reportPublic FDA data

NDC 55150-338 - LEUPROLIDE ACETATE

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
55150-338
Package NDCs from labels
55150-338-01
Manufacturer
Eugia US LLC | EUGIA Pharma Specialities Limited
Effective date
2026-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEUPROLIDE ACETATE - Eugia US LLC | EUGIA Pharma Specialities LimitedEugia US LLC | EUGIA Pharma Specialities Limited2026-05-08Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-338-01LEUPROLIDE ACETATE1 in 1 CARTONINJECTION, SOLUTION1 mg in 0.2mL6
55150-338-01LEUPROLIDE ACETATE2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL1 mg in 0.2mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-338LEUPROLIDE ACETATE KIT [EUGIA US LLC]3Unmatched20241228_49a1d0c1-304c-46f2-a780-bd940ae1ced0.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 132 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLSarnova, Inc.62be13a6-da24-4ab0-b0f4-f2894324c20c2024-12-06WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Instant Hand AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2998b2bd-6208-4cb4-982b-0ffb97d7d75d2024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.68003c71-5959-476f-b252-1f131e9305e22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.b621b4cd-20db-44d8-b114-a977deea8eb42024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.c3a053ba-65fe-4540-9c81-29700cda5efa2024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2989afeb-8451-4a72-8456-195cd5117a412024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 1.25BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.17092ebf-8e57-4e1a-9bba-87a662c361c02024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.3ed3332e-f888-4b9c-aab7-99f8719b835e2024-12-05WarningsExact identifier
application number: M003
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
ALPET E3 HAND SANITIZERISOPROPYL ALCOHOLBest Sanitizers, Inc.08055e08-039d-43da-adad-adaf6639fa842024-12-05WarningsExact identifier
unii: ND2M416302
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
application number: M003
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
application number: M003
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
application number: M003
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact identifier
application number: M003
OPS RANCH HAND ANTIBACTERIAL FOAMINGCHLOROXYLENOLArcher Manufacturing, Inc.d8187090-8423-062e-e053-2a95a90aad182024-12-05WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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