FDA.reportPublic FDA data

NDC 58198-0078 - Zorbium

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
58198-0078
Package NDCs from labels
58198-0078-1, 58198-0078-2
Manufacturer
Elanco US Inc. | SpecGx LLC | Ivy Animal Health, Inc.
Effective date
2022-04-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zorbium TM (buprenorphine transdermal solution)Elanco US Inc. | SpecGx LLC | Ivy Animal Health, Inc.2022-04-25PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0078-1Zorbium0.4 mL in 1 TUBESOLUTION0.42
58198-0078-1Zorbium10 in 1 CARTONSOLUTION102
58198-0078-2Zorbium1 mL in 1 TUBESOLUTION12
58198-0078-2Zorbium10 in 1 CARTONSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0078ZORBIUM (BUPRENORPHINE) SOLUTION [ELANCO US INC.]24 package rows20220429_c00709bf-12fd-40fc-9cff-7a7e7390fcb8.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 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBLOCADEBUPRENORPHINEIndivior Inc.6189fb21-9432-45f8-8481-0bfaf3ccde952026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2063d5bf-b3bc-4e73-9046-7e994446ab502026-06-18Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfc2755a5-3292-4b49-872d-e22c386a4e442026-06-11Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINERhodes Pharmaceuticals LLC2738feae-316e-426f-971c-5f142ac01b602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINETeva Pharmaceuticals USA, Inc.36995ce3-b515-447b-baa9-aa14f84060d82026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
ButransBUPRENORPHINEKnoa Pharma LLC794aa355-66de-41b8-aedf-f2c40f6bc6642026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEINGENUS PHARMACEUTICALS, LLC186e3be6-8bc0-4bb9-96f5-429d53632f452026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEAveva Drug Delivery Systems Inc.1aae9b13-7431-42ef-8558-14a2325820e62026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONELannett Company, Inc.14eaa94a-cc8a-4e1e-8cfb-5c976c96c6062026-01-28Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BuprenorphineBUPRENORPHINEAmneal Pharmaceuticals NY LLCc7d079fb-507f-436f-b794-2171b7d970672026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
BRIXADIBUPRENORPHINEBraeburn Inc.5d8a8fd0-8619-422a-a664-d1d2e8970f482025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ
buprenorphine transdermal systemBUPRENORPHINEAlvogen Inc.315284b8-32ab-d34a-ea02-f501c6131bcc2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 40D3SCR4GZ

Reported adverse events (FAERS/openFDA)#

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