Prescription drug · NDA
Ravicti (Glycerol phenylbutyrate) NDC 75987-050
Glycerol phenylbutyrate 1.1 g/mL · Liquid · Oral · Horizon Therapeutics USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75987-050-06 | 75987005006 | 1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLEMarketed from Feb 28, 2013 | |
| 75987-050-07 | 75987005007 | 4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLEMarketed from Feb 28, 2013 |
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)
- Ravicti
- Generic name (nonproprietary)
- glycerol phenylbutyrate
- Active ingredients
- Glycerol phenylbutyrate — 1.1 g/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Horizon Therapeutics USA, Inc.NDC labeler code 75987
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203284
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22SPL ID a58b617c-635a-4a67-9f27-f9c93f8cba22SPL set ID 900e7dc0-9afe-4f50-80de-90567bb78519RxCUI 1368453, 1368459UNII ZH6F1VCV7B
- 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
N475987005006followed by a unit qualifier and the quantityPackage 75987-0050-06. 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)
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels. The safety and efficacy of RAVICTI for the treatment of N- acetylglutamate synthase (NAGS) deficiency …
Excerpt only. Read the full label for complete information.
About NDC 75987-050
- What is NDC 75987-050?
- 75987-050 is the product NDC for Ravicti (glycerol phenylbutyrate), Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Horizon Therapeutics USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ravicti (Glycerol phenylbutyrate).
- What is the active ingredient?
- Glycerol 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 Ravicti?
- 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.
Other NDCs under NDA 203284
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 |
|---|---|---|---|---|
| glycerol phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Lupin Pharmaceuticals, Inc. | 70748-425 |