NDC codes

FDA NDC Directory
Product NDC (as listed)70710-2180Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-2180Add 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 NDC11-digit (billing)PackageCopy
70710-2180-8707102180081 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLEMarketed from Mar 23, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220418
Marketing start
Listing expires
Other FDA classes
Ammonium Ion Binding Activity (Mechanism)
Identifiers
Product ID 70710-2180_47ef97e0-8853-4254-b969-1a489764cec1SPL ID 47ef97e0-8853-4254-b969-1a489764cec1SPL set ID d08fd548-7eb8-4f6f-b664-b0fff6f30065RxCUI 199369UNII NT6K61736TUPC 0370710218089
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

N470710218008 followed by a unit qualifier and the quantity

Package 70710-2180-08. 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)

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 70710-2180

What is NDC 70710-2180?
70710-2180 is the product NDC for Sodium phenylbutyrate, Sodium phenylbutyrate 500 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sodium phenylbutyrateSodium phenylbutyrate 500 mg/1TabletOralNavinta LLC68475-01168475-0011-01
sodium phenylbutyrateSodium phenylbutyrate 500 mg/1TabletOralGLENMARK PHARMACEUTICALS INC., USA68462-85368462-0853-20
Sodium PhenylbutyrateSodium phenylbutyrate .94 g/gPowderOralPar Health USA, LLC49884-00649884-0006-04
Sodium Phenylbutyratesodium phenylbutyrate tablets, 500 mgSodium phenylbutyrate 500 mg/1TabletOralPar Health USA, LLC49884-17049884-0170-04

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
ProductStrengthForm · routeLabelerProduct NDC
Sodium phenylbutyrateSodium phenylbutyrate 500 mg/1TabletOralNavinta LLC68475-011

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