Prescription drug · NDA
Contrave Extended-Release NDC 51267-890
naltrexone hydrochloride and bupropion hydrochloride · Naltrexone hydrochloride 8 mg/1; Bupropion hydrochloride 90 mg/1 · Tablet, Extended release · Oral · Nalpropion Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51267-890-07 | 51267089007 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07)Marketed from Jan 14, 2021 · Sample package | |
| 51267-890-99 | 51267089099 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99)Marketed from Oct 22, 2014 |
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)
- Contrave Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- naltrexone hydrochloride and bupropion hydrochloride
- Active ingredients
- Naltrexone hydrochloride — 8 mg/1Bupropion hydrochloride — 90 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Nalpropion Pharmaceuticals LLCNDC labeler code 51267
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200063
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 51267-890_8e7e5582-7a35-4ec7-85e7-b88a98d1bd23SPL ID 8e7e5582-7a35-4ec7-85e7-b88a98d1bd23SPL set ID 485ff360-32c8-11df-928b-0002a5d5c51bRxCUI 1551468, 1551474UNII Z6375YW9SF, ZG7E5POY8OUPC 0351267890997
- Pharmacologic class
- Aminoketone; Opioid Antagonist
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451267089007followed by a unit qualifier and the quantityPackage 51267-0890-07. 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)
CONTRAVE is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. CONTRAVE is a combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: The effect of CONTRAVE on cardiovascu…
Excerpt only. Read the full label for complete information.
About NDC 51267-890
- What is NDC 51267-890?
- 51267-890 is the product NDC for Contrave Extended-Release, Naltrexone hydrochloride 8 mg/1; Bupropion hydrochloride 90 mg/1 tablet, extended release, listed with the FDA by Nalpropion Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Contrave Extended-Release (Naltrexone hydrochloride and bupropion hydrochloride).
- What is the active ingredient?
- Naltrexone hydrochloride, Bupropion hydrochloride.
- Who is the labeler?
- Nalpropion Pharmaceuticals LLC, NDC labeler code 51267. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Contrave Extended-Release?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.