NDC codes

FDA NDC Directory
Product NDC (as listed)49884-006Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0006Add 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
49884-006-04498840006041 BOTTLE in 1 CARTON (49884-006-04) / 250 g in 1 BOTTLEMarketed from Aug 31, 2016

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 — .94 g/g
Dosage form
Powder
Route
Oral
Labeler
Par Health USA, LLCNDC labeler code 49884
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203918
Marketing start
Listing expires
Other FDA classes
Ammonium Ion Binding Activity (Mechanism)
Identifiers
Product ID 49884-006_583e7b91-8e00-4c38-a78f-d8948ea95a20SPL ID 583e7b91-8e00-4c38-a78f-d8948ea95a20SPL set ID 639f5c7e-9f6d-47fb-a417-2be076176a78RxCUI 984105UNII NT6K61736TUPC 0349884006044
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

N449884000604 followed by a unit qualifier and the quantity

Package 49884-0006-04. 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 powder is 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 to …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49884-006

What is NDC 49884-006?
49884-006 is the product NDC for Sodium Phenylbutyrate, Sodium phenylbutyrate .94 g/g powder, listed with the FDA by Par Health USA, 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?
Par Health USA, LLC, NDC labeler code 49884. 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/1TabletOralZydus Pharmaceuticals USA Inc.70710-218070710-2180-08
sodium phenylbutyrateSodium phenylbutyrate 500 mg/1TabletOralGLENMARK PHARMACEUTICALS INC., USA68462-85368462-0853-20
Sodium Phenylbutyratesodium phenylbutyrate tablets, 500 mgSodium phenylbutyrate 500 mg/1TabletOralPar Health USA, LLC49884-17049884-0170-04

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