brixadi

Generic: buprenorphine

Labeler: braeburn inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name brixadi
Generic Name buprenorphine
Labeler braeburn inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

buprenorphine 16 mg/.32mL

Manufacturer
Braeburn Inc.

Identifiers & Regulatory

Product NDC 58284-216
Product ID 58284-216_4e1985eb-1302-42e0-ac79-10b0a492966a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210136
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2023-06-06

Pharmacologic Class

Established (EPC)
partial opioid agonist [epc]
Mechanism of Action
partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58284216
Hyphenated Format 58284-216

Supplemental Identifiers

RxCUI
2639021 2639027 2639029 2639030 2639031 2639032 2639033 2639034 2639036 2639039 2639041 2639042 2639043 2639044
UNII
40D3SCR4GZ
NUI
N0000175689 N0000175685

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brixadi (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number NDA210136 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 16 mg/.32mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

58284-216-01 1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS

Ingredients (1)

buprenorphine (16 mg/.32mL)

Linked Drug Pages (1)

BRIXADI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4e1985eb-1302-42e0-ac79-10b0a492966a", "openfda": {"nui": ["N0000175689", "N0000175685"], "unii": ["40D3SCR4GZ"], "rxcui": ["2639021", "2639027", "2639029", "2639030", "2639031", "2639032", "2639033", "2639034", "2639036", "2639039", "2639041", "2639042", "2639043", "2639044"], "spl_set_id": ["5d8a8fd0-8619-422a-a664-d1d2e8970f48"], "pharm_class_epc": ["Partial Opioid Agonist [EPC]"], "pharm_class_moa": ["Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Braeburn Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (58284-216-01)  / .32 mL in 1 SYRINGE, GLASS", "package_ndc": "58284-216-01", "marketing_start_date": "20230606"}], "brand_name": "BRIXADI", "product_id": "58284-216_4e1985eb-1302-42e0-ac79-10b0a492966a", "dosage_form": "INJECTION", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "58284-216", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE", "labeler_name": "Braeburn Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BRIXADI", "active_ingredients": [{"name": "BUPRENORPHINE", "strength": "16 mg/.32mL"}], "application_number": "NDA210136", "marketing_category": "NDA", "marketing_start_date": "20230606", "listing_expiration_date": "20271231"}