What is NDC 59651-988?

59651-988 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glycerol Phenylbutyrate NDC 59651-988 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-988Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0988Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59651-988-25	59651098825	1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASSMarketed from Apr 15, 2026

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
Active ingredients: Glycerol phenylbutyrate — 1.1 g/mL
Dosage form: Liquid
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220313
Marketing start: Apr 15, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 59651-988_11981aec-dbf1-4906-acfd-3c10708fe0a6SPL ID 11981aec-dbf1-4906-acfd-3c10708fe0a6SPL set ID 11981aec-dbf1-4906-acfd-3c10708fe0a6RxCUI 1368453UNII ZH6F1VCV7BUPC 0359651988251
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

N459651098825 followed by a unit qualifier and the quantity

Package 59651-0988-25. 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 Apr 9, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 59651-988

What is NDC 59651-988?: 59651-988 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Glycerol Phenylbutyrate.
What is the active ingredient?: Glycerol phenylbutyrate.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Glycerol Phenylbutyrate NDCs
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	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
Glycerol Phenylbutyrateglycerol phenylbutyrate oral	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Par Health USA, LLC	49884-264	49884-0264-95