Prescription drug · NDA
Suboxone NDC 12496-1202
buprenorphine hydrochloride, naloxone hydrochloride · Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 · Film, Soluble · Buccal, Sublingual · INDIVIOR INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 12496-1202-3 | 12496120203 | 30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1)Marketed from Sep 13, 2010 |
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)
- Suboxone
- Generic name (nonproprietary)
- buprenorphine hydrochloride, naloxone hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — 2 mg/1Naloxone hydrochloride — .5 mg/1
- Dosage form
- Film, Soluble
- Route
- Buccal, Sublingual
- Labeler
- INDIVIOR INC.NDC labeler code 12496
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022410
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 12496-1202_ad5a289a-6285-4b2d-b7ad-e4812169dd58SPL ID ad5a289a-6285-4b2d-b7ad-e4812169dd58SPL set ID 8a5edcf9-828c-4f97-b671-268ab13a8ecdRxCUI 1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063UNII 56W8MW3EN1, F850569PQRUPC 0312496120835
- Pharmacologic class
- Opioid Antagonist; 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 HCPCS code in Med-Code's directory. Buccal, Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N412496120203followed by a unit qualifier and the quantityPackage 12496-1202-03. 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 .
Indications (excerpt from the label)
SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. SUBOXONE® sublingual film contains buprenorphine, a partial‐opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 12496-1202
- What is NDC 12496-1202?
- 12496-1202 is the product NDC for Suboxone, Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1 film, soluble, 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?
- Suboxone (Buprenorphine hydrochloride, naloxone hydrochloride).
- What is the active ingredient?
- Buprenorphine hydrochloride, Naloxone hydrochloride.
- 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 Suboxone?
- 3 other product NDCs are listed under this name. See all Suboxone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Suboxone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1204 | 12496-1204-03 |
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1212 | 12496-1212-03 |
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1208 | 12496-1208-03 |
Other NDCs under NDA 022410
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 |
|---|---|---|---|---|
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1204 |
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1208 |
| Suboxonebuprenorphine hydrochloride, naloxone hydrochloride | Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1 | Film, SolubleBuccal, Sublingual | INDIVIOR INC. | 12496-1212 |