What is NDC 68475-807?

68475-807 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. 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 68475-807 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-807Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0807Add 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
68475-807-01	68475080701	1 BOTTLE in 1 CARTON (68475-807-01) / 25 mL in 1 BOTTLEMarketed from Jul 11, 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: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220568
Marketing start: Jul 11, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 68475-807_209d6843-10de-43fc-9ae1-2cfd2ff8ee6cSPL ID 209d6843-10de-43fc-9ae1-2cfd2ff8ee6cSPL set ID 15c4da9f-f5e0-4628-b55f-3730be3e1c39RxCUI 1368453UNII ZH6F1VCV7BUPC 0368475807013
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

N468475080701 followed by a unit qualifier and the quantity

Package 68475-0807-01. 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 Jun 23, 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 68475-807

What is NDC 68475-807?: 68475-807 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by Navinta LLC. 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?: Navinta LLC, NDC labeler code 68475. 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	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	Aurobindo Pharma Limited	59651-988	59651-0988-25
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

Other NDCs under ANDA 220568

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 220568
Product	Strength	Form · route	Labeler	Product NDC
Glycerol Phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Zydus Pharmaceuticals USA Inc.	70710-2193