Prescription drug · NDA
Buphenyl (Sodium phenylbutyrate) NDC 75987-070
Sodium phenylbutyrate .94 g/g · Powder · Oral · Horizon Therapeutics USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75987-070-09 | 75987007009 | 1 BOTTLE in 1 CARTON (75987-070-09) / 250 g in 1 BOTTLEMarketed from Apr 30, 1996 |
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)
- Buphenyl
- Generic name (nonproprietary)
- sodium phenylbutyrate
- Active ingredients
- Sodium phenylbutyrate — .94 g/g
- Dosage form
- Powder
- Route
- Oral
- Labeler
- Horizon Therapeutics USA, Inc.NDC labeler code 75987
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020573
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 75987-070_3178e0bc-ebb7-4ddd-be43-630ff87eeb02SPL ID 3178e0bc-ebb7-4ddd-be43-630ff87eeb02SPL set ID 463a36fa-3eb2-4326-8bd0-c8c7a11bca3aRxCUI 199369, 213196, 984105, 984107UNII NT6K61736T
- Pharmacologic class
- Nitrogen Binding Agent
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
N475987007009followed by a unit qualifier and the quantityPackage 75987-0070-09. 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)
INDICATIONS AND USAGE BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. …
Excerpt only. Read the full label for complete information.
About NDC 75987-070
- What is NDC 75987-070?
- 75987-070 is the product NDC for Buphenyl (sodium phenylbutyrate), Sodium phenylbutyrate .94 g/g powder, listed with the FDA by Horizon Therapeutics USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Buphenyl (Sodium phenylbutyrate).
- What is the active ingredient?
- Sodium phenylbutyrate.
- Who is the labeler?
- Horizon Therapeutics USA, Inc., NDC labeler code 75987. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Buphenyl?
- 1 other product NDC are listed under this name. See all Buphenyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Buphenyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Buphenylsodium phenylbutyrate | Sodium phenylbutyrate 500 mg/1 | TabletOral | Horizon Therapeutics USA, Inc. | 75987-060 | 75987-0060-08 |