Prescription drug · NDA
Sublocade (Buprenorphine) NDC 12496-0100
Buprenorphine 100 mg/1 · Solution · Subcutaneous · Indivior Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 12496-0100-1 | 1249601000112496010001 | 1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5)Marketed from Feb 26, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Sublocade
- Generic name (nonproprietary)
- buprenorphine
- Active ingredients
- Buprenorphine — 100 mg/1
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- Indivior Inc.NDC labeler code 12496
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209819
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 12496-0100_5799c0fd-6d82-f48a-e063-6394a90a63d6SPL ID 5799c0fd-6d82-f48a-e063-6394a90a63d6SPL set ID 6189fb21-9432-45f8-8481-0bfaf3ccde95RxCUI 1996184, 1996189, 1996192, 1996193UNII 40D3SCR4GZUPC 0312496030011, 0312496010013
- 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
N412496010001followed by a unit qualifier and the quantityPackage 12496-0100-01. 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)
SUBLOCADE 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. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBLOCADE contains buprenorphine, a partial opioid agonist, and 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 ) SUBLOCADE should be used as part of a complete treatmen…
Excerpt only. Read the full label for complete information.
About NDC 12496-0100
- What is NDC 12496-0100?
- 12496-0100 is the product NDC for Sublocade (buprenorphine), Buprenorphine 100 mg/1 solution, listed with the FDA by Indivior Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sublocade (Buprenorphine).
- What is the active ingredient?
- Buprenorphine.
- Who is the labeler?
- Indivior Inc., NDC labeler code 12496. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sublocade?
- 1 other product NDC are listed under this name. See all Sublocade NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sublocade products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sublocadebuprenorphine | Buprenorphine 300 mg/1 | SolutionSubcutaneous | Indivior Inc. | 12496-0300 | 12496-0300-01 |
Other NDCs under NDA 209819
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 |
|---|---|---|---|---|
| Sublocadebuprenorphine | Buprenorphine 300 mg/1 | SolutionSubcutaneous | Indivior Inc. | 12496-0300 |