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
- 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 |