FDA.reportPublic FDA data

BRIXADI

Product NDC
58284-296
11-digit product format
582840296
Labeler code
58284
Product ID
58284-296_4e1985eb-1302-42e0-ac79-10b0a492966a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPRENORPHINE
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Braeburn Inc.
Application
NDA210136
Marketing category
NDA
Marketing start
2023-06-06
Substance
BUPRENORPHINE
Active strength
96 mg/.27mL
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRIXADI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE96 mg/.27mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40D3SCR4GZ
Rxcui2639021, 2639027, 2639029, 2639030, 2639031, 2639032, 2639033, 2639034, 2639036, 2639039, 2639041, 2639042, 2639043, 2639044

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58284-296-01BRIXADI1 in 1 CARTONINJECTION16
58284-296-01BRIXADI0.27 mL in 1 SYRINGE, GLASSINJECTION0.276

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58284-296BRIXADI (BUPRENORPHINE) INJECTION [BRAEBURN INC.]5Current NDC, 2 package rows20250112_5d8a8fd0-8619-422a-a664-d1d2e8970f48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639044Brixadi 128 MG in 0.36 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639030Brixadi 16 MG in 0.32 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639032Brixadi 24 MG in 0.48 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639034Brixadi 32 MG in 0.64 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639039Brixadi 64 MG in 0.18 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639027Brixadi 8 MG in 0.16 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639042Brixadi 96 MG in 0.27 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639043buprenorphine 128 MG in 0.36 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639029buprenorphine 16 MG in 0.32 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639031buprenorphine 24 MG in 0.48 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639033buprenorphine 32 MG in 0.64 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639036buprenorphine 64 MG in 0.18 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639021buprenorphine 8 MG in 0.16 ML Weekly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639041buprenorphine 96 MG in 0.27 ML Monthly Extended Release Prefilled SyringePSN5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390270.16 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390390.18 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390420.27 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390300.32 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390440.36 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390320.48 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390340.64 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]SBD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390210.16 ML buprenorphine 50 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390360.18 ML buprenorphine 356 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390410.27 ML buprenorphine 356 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390290.32 ML buprenorphine 50 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390430.36 ML buprenorphine 356 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390310.48 ML buprenorphine 50 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390330.64 ML buprenorphine 50 MG/ML Prefilled SyringeSCD5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390270.16 ML Brixadi 50 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390390.18 ML Brixadi 356 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390420.27 ML Brixadi 356 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390300.32 ML Brixadi 50 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390440.36 ML Brixadi 356 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390320.48 ML Brixadi 50 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
26390340.64 ML Brixadi 50 MG/ML Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639044Brixadi 128 MG per 0.36 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639030Brixadi 16 MG per 0.32 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639032Brixadi 24 MG per 0.48 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639034Brixadi 32 MG per 0.64 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639039Brixadi 64 MG per 0.18 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639027Brixadi 8 MG per 0.16 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639042Brixadi 96 MG per 0.27 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639043buprenorphine 128 MG per 0.36 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639029buprenorphine 16 MG per 0.32 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639031buprenorphine 24 MG per 0.48 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639033buprenorphine 32 MG per 0.64 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639036buprenorphine 64 MG per 0.18 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639021buprenorphine 8 MG per 0.16 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486
2639041buprenorphine 96 MG per 0.27 ML extended release Prefilled SyringeSY5d8a8fd0-8619-422a-a664-d1d2e8970f486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58284-296-01582840296011 SYRINGE, GLASS in 1 CARTON (58284-296-01) / .27 mL in 1 SYRINGE, GLASS2023-06-06NoNoCurrent