Prescription drug · ANDA
Glycerol Phenylbutyrate (Glycerol phenylbutyrate oral) NDC 49884-264
Glycerol phenylbutyrate 1.1 g/mL · Liquid · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-264-95 | 49884026495 | 1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLEMarketed from Oct 17, 2025 |
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)
- Glycerol Phenylbutyrate
- Generic name (nonproprietary)
- glycerol phenylbutyrate oral
- Active ingredients
- Glycerol phenylbutyrate — 1.1 g/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205742
- Marketing start
- Listing expires
- Other FDA classes
- Ammonium Ion Binding Activity (Mechanism)
- Identifiers
- Product ID 49884-264_88787621-3d7b-4665-9535-9e14d67aba66SPL ID 88787621-3d7b-4665-9535-9e14d67aba66SPL set ID e78f2dfd-fb39-4e4b-a639-64591d282ca6RxCUI 1368453UNII ZH6F1VCV7BUPC 0349884264956
- 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
N449884026495followed by a unit qualifier and the quantityPackage 49884-0264-95. 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)
Glycerol phenylbutyrate oral liquid 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. Glycerol phenylbutyrate oral liquid 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: Glycerol phenylbutyrate oral liquid 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 eff…
Excerpt only. Read the full label for complete information.
About NDC 49884-264
- What is NDC 49884-264?
- 49884-264 is the product NDC for Glycerol Phenylbutyrate (glycerol phenylbutyrate oral), Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glycerol Phenylbutyrate (Glycerol Phenylbutyrate oral).
- What is the active ingredient?
- Glycerol phenylbutyrate.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glycerol Phenylbutyrate?
- 7 other product NDCs are listed under this name. See all Glycerol Phenylbutyrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glycerol Phenylbutyrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glycerol Phenylbutyrateglycerol phenylbutyrate oral | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Camber Pharmaceuticals, Inc. | 31722-605 | 31722-0605-3131722-0605-32 |
| Glycerol Phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Navinta LLC | 68475-807 | 68475-0807-01 |
| Glycerol Phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Zydus Pharmaceuticals USA Inc. | 70710-2193 | 70710-2193-05 |
| Glycerol phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Teva Pharmaceuticals, Inc. | 0480-3777 | 00480-3777-58 |
| Glycerol Phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Aurobindo Pharma Limited | 59651-988 | 59651-0988-25 |
| Glycerol phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Novadoz Pharmaceuticals LLC | 72205-331 | 72205-0331-5772205-0331-58 |
| glycerol phenylbutyrate | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Lupin Pharmaceuticals, Inc. | 70748-425 | 70748-0425-01 |
Other NDCs under ANDA 205742
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 Phenylbutyrateglycerol phenylbutyrate oral | Glycerol phenylbutyrate 1.1 g/mL | LiquidOral | Camber Pharmaceuticals, Inc. | 31722-605 |