FDA.reportPublic FDA data

NDC 12496-0100-2 - SUBLOCADE

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
12496-0100
Requested NDC
12496-0100-2
Package NDCs from labels
12496-0100-5, 12496-0100-2, 12496-0100-1
Manufacturer
Indivior Inc. | SGS North America Inc. | Eurofins Lancaster Laboratories, LLC | Curia New Mexico, LLC | Curia New Mexico, LLC. | Curia Global, Inc. | Sharp Packaging Services, LLC | Nelson Laboratories, LLC | Indivior UK Limited | Wickham Micro Limited | QUOTIENT SCIENCES (ALNWICK) LIMITED | Sterling Pharma Solutions Limited
Effective date
2026-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SUBLOCADEIndivior Inc. | SGS North America Inc. | Eurofins Lancaster Laboratories, LLC | Curia New Mexico, LLC | Curia New Mexico, LLC. | Curia Global, Inc. | Sharp Packaging Services, LLC | Nelson Laboratories, LLC | Indivior UK Limited | Wickham Micro Limited | QUOTIENT SCIENCES (ALNWICK) LIMITED | Sterling Pharma Solutions Limited2026-07-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12496-0100-1SUBLOCADE1 in 1 CARTONSOLUTION142
12496-0100-2SUBLOCADE1 in 1 POUCHSOLUTION142
12496-0100-5SUBLOCADE1 in 1 SYRINGESOLUTION142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12496-0100SUBLOCADE (BUPRENORPHINE) SOLUTION [INDIVIOR INC.]38Current NDC, Legacy NDC, 3 package rows20250309_6189fb21-9432-45f8-8481-0bfaf3ccde95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12496-0100-1ML - Milliliter12496-010098083f46-e176-4dfa-ae03-77e1983e2fa112018-01-12
12496-0100-2ML - Milliliter12496-010058419e46-1521-42e1-9f62-5a37c7de0c9012018-03-08
12496-0100-5ML - Milliliter12496-0100ed446cab-fe1d-49b3-b402-087b5f2cbaf112019-01-24

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
application number: NDA209819
ndc (package): 12496-0300-2
ndc (package): 12496-0300-1
ndc (package): 12496-0100-5
ndc (package): 12496-0100-2
ndc (package): 12496-0300-5
ndc (package): 12496-0100-1
ndc (product): 12496-0100
ndc (product): 12496-0300
ndc11 (package): 12496010002
rxcui: 1996189
rxcui: 1996184
rxcui: 1996193
rxcui: 1996192
spl id: 5799c0fd-6d82-f48a-e063-6394a90a63d6
spl set id: 6189fb21-9432-45f8-8481-0bfaf3ccde95
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