NDC codes

FDA NDC Directory
Product NDC (as listed)31722-891Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0891Add 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
31722-891-18317220891181 BOTTLE in 1 CARTON (31722-891-18) / 180 mL in 1 BOTTLEMarketed from Jan 1, 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 oxybate
Generic name (nonproprietary)
sodium oxybate
Active ingredients
Sodium oxybate — .5 g/mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210523
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers
Product ID 31722-891_ed6f9595-7f10-4822-8dca-57b219fffe50SPL ID ed6f9595-7f10-4822-8dca-57b219fffe50SPL set ID 5dcf9a5c-312b-420b-82f3-42177d8f9ee4RxCUI 349482UNII 7G33012534UPC 0331722891189
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

N431722089118 followed by a unit qualifier and the quantity

Package 31722-0891-18. 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 . 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 with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium oxybate oral solutio n is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (1).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210523

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

FDA NDC Directory listings under ANDA 210523
ProductStrengthForm · routeLabelerProduct NDC
sodium oxybateSodium oxybate .5 g/mLSolutionOralXLCare Pharmaceuticals, Inc.72865-349

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