sodium oxybate NDC 0054-9628

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-9628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-9628Add 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
0054-9628-57	00054962857	180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)Marketed from Jan 3, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 oxybate
Generic name (nonproprietary): sodium oxybate
Active ingredients: Sodium oxybate — .5 g/mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021196
Marketing start: Jan 3, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01SPL ID 599719a1-b644-4ece-b0c0-ce8d85378e01SPL set ID bcef2c95-35e9-464d-9025-652acff769e7RxCUI 349482UNII 7G33012534
Pharmacologic class: Central Nervous System Depressant

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

N400054962857 followed by a unit qualifier and the quantity

Package 00054-9628-57. 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 Apr 25, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Sodium Oxybate Oral Solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021196

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

FDA NDC Directory listings under NDA 021196
Product	Strength	Form · route	Labeler	Product NDC
Xyremsodium oxybate	Sodium oxybate .5 g/mL	SolutionOral	Jazz Pharmaceuticals, Inc.	68727-100