Prescription drug · NDA
Brixadi (Buprenorphine) NDC 58284-264
Buprenorphine 64 mg/.18mL · Injection · Subcutaneous · Braeburn Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58284-264-01 | 5828402640158284026401 | 1 SYRINGE, GLASS in 1 CARTON (58284-264-01) / .18 mL in 1 SYRINGE, GLASSMarketed from Jun 6, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brixadi
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine — 64 mg/.18mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Braeburn Inc.NDC labeler code 58284
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210136
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 58284-264_4e1985eb-1302-42e0-ac79-10b0a492966aSPL ID 4e1985eb-1302-42e0-ac79-10b0a492966aSPL set ID 5d8a8fd0-8619-422a-a664-d1d2e8970f48RxCUI 2639021, 2639027, 2639029, 2639030, 2639031, 2639032, 2639033, 2639034, 2639036, 2639039, 2639041, 2639042, 2639043, 2639044UNII 40D3SCR4GZ
- Pharmacologic class
- Partial Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N458284026401followed by a unit qualifier and the quantityPackage 58284-0264-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. BRIXADI contains buprenorphine, a partial opioid agonist. BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. ( 1 ) BRIXADI should be used as part of a complete treatment pl…
Excerpt only. Read the full label for complete information.
About NDC 58284-264
- What is NDC 58284-264?
- 58284-264 is the product NDC for Brixadi (buprenorphine), Buprenorphine 64 mg/.18mL injection, listed with the FDA by Braeburn Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brixadi (Buprenorphine).
- What is the active ingredient?
- Buprenorphine.
- Who is the labeler?
- Braeburn Inc., NDC labeler code 58284. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brixadi?
- 6 other product NDCs are listed under this name. See all Brixadi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brixadi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brixadibuprenorphine | Buprenorphine 8 mg/.16mL | InjectionSubcutaneous | Braeburn Inc. | 58284-208 | 58284-0208-01 |
| Brixadibuprenorphine | Buprenorphine 16 mg/.32mL | InjectionSubcutaneous | Braeburn Inc. | 58284-216 | 58284-0216-01 |
| Brixadibuprenorphine | Buprenorphine 24 mg/.48mL | InjectionSubcutaneous | Braeburn Inc. | 58284-224 | 58284-0224-01 |
| Brixadibuprenorphine | Buprenorphine 128 mg/.36mL | InjectionSubcutaneous | Braeburn Inc. | 58284-228 | 58284-0228-01 |
| Brixadibuprenorphine | Buprenorphine 32 mg/.64mL | InjectionSubcutaneous | Braeburn Inc. | 58284-232 | 58284-0232-01 |
| Brixadibuprenorphine | Buprenorphine 96 mg/.27mL | InjectionSubcutaneous | Braeburn Inc. | 58284-296 | 58284-0296-01 |
Other NDCs under NDA 210136
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brixadibuprenorphine | Buprenorphine 8 mg/.16mL | InjectionSubcutaneous | Braeburn Inc. | 58284-208 |
| Brixadibuprenorphine | Buprenorphine 16 mg/.32mL | InjectionSubcutaneous | Braeburn Inc. | 58284-216 |
| Brixadibuprenorphine | Buprenorphine 24 mg/.48mL | InjectionSubcutaneous | Braeburn Inc. | 58284-224 |
| Brixadibuprenorphine | Buprenorphine 128 mg/.36mL | InjectionSubcutaneous | Braeburn Inc. | 58284-228 |
| Brixadibuprenorphine | Buprenorphine 32 mg/.64mL | InjectionSubcutaneous | Braeburn Inc. | 58284-232 |
| Brixadibuprenorphine | Buprenorphine 96 mg/.27mL | InjectionSubcutaneous | Braeburn Inc. | 58284-296 |