What is NDC 68475-011?

68475-011 is the product NDC for Sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, 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 Sodium phenylbutyrate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sodium phenylbutyrate NDC 68475-011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0011Add 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
68475-011-01	68475001101	1 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLEMarketed from Jul 10, 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): Sodium phenylbutyrate
Generic name (nonproprietary): sodium phenylbutyrate
Active ingredients: Sodium phenylbutyrate — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220418
Marketing start: Jul 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 68475-011_5da41af8-4b7d-4703-9e7e-8b4d7ffed8b6SPL ID 5da41af8-4b7d-4703-9e7e-8b4d7ffed8b6SPL set ID c564778d-b285-4d1d-a641-9d4ee76079cfRxCUI 199369UNII NT6K61736TUPC 0368475011014
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

N468475001101 followed by a unit qualifier and the quantity

Package 68475-0011-01. 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 Jul 9, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Sodium phenylbutyrate tablets are indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68475-011

What is NDC 68475-011?: 68475-011 is the product NDC for Sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, 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?: Sodium phenylbutyrate.
What is the active ingredient?: Sodium 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 Sodium phenylbutyrate?: 4 other product NDCs are listed under this name. See all Sodium 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 Sodium phenylbutyrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sodium phenylbutyrate	Sodium phenylbutyrate 500 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-2180	70710-2180-08
sodium phenylbutyrate	Sodium phenylbutyrate 500 mg/1	TabletOral	GLENMARK PHARMACEUTICALS INC., USA	68462-853	68462-0853-20
Sodium Phenylbutyrate	Sodium phenylbutyrate .94 g/g	PowderOral	Par Health USA, LLC	49884-006	49884-0006-04
Sodium Phenylbutyratesodium phenylbutyrate tablets, 500 mg	Sodium phenylbutyrate 500 mg/1	TabletOral	Par Health USA, LLC	49884-170	49884-0170-04

Other NDCs under ANDA 220418

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

FDA NDC Directory listings under ANDA 220418
Product	Strength	Form · route	Labeler	Product NDC
Sodium phenylbutyrate	Sodium phenylbutyrate 500 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-2180