What is NDC 68462-853?

68462-853 is the product NDC for sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, listed with the FDA by GLENMARK PHARMACEUTICALS INC., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

GLENMARK PHARMACEUTICALS INC., USA, NDC labeler code 68462. 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 68462-853 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-853Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0853Add 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
68462-853-20	68462085320	250 TABLET in 1 BOTTLE (68462-853-20)Marketed from Nov 1, 2022

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: GLENMARK PHARMACEUTICALS INC., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216462
Marketing start: Nov 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 68462-853_060b5266-8881-4270-b62d-df8e49ecfd4bSPL ID 060b5266-8881-4270-b62d-df8e49ecfd4bSPL set ID 0c76d25b-abac-41a3-a547-4fa4796bf7a4RxCUI 199369UNII NT6K61736TUPC 0368462853207
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

N468462085320 followed by a unit qualifier and the quantity

Package 68462-0853-20. 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 Jan 28, 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 68462-853

What is NDC 68462-853?: 68462-853 is the product NDC for sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, listed with the FDA by GLENMARK PHARMACEUTICALS INC., USA. 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?: GLENMARK PHARMACEUTICALS INC., USA, NDC labeler code 68462. 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	Navinta LLC	68475-011	68475-0011-01
Sodium phenylbutyrate	Sodium phenylbutyrate 500 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-2180	70710-2180-08
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