What is NDC 65162-065?

65162-065 is the product NDC for Sodium Oxybate, Sodium oxybate 500 mg/mL solution, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Oxybate?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sodium Oxybate NDC 65162-065 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-065Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0065Add 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
65162-065-87	6516200658765162006587	1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLEMarketed from Sep 12, 2025

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 — 500 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203631
Marketing start: Sep 12, 2025
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
Identifiers: Product ID 65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2SPL ID fb0e7d54-bf58-46d7-8561-9a270771f0d2SPL set ID 5a9e9045-f04d-46eb-8396-2495c6090a31RxCUI 349482UNII 7G33012534UPC 0365162065879
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

N465162006587 followed by a unit qualifier and the quantity

Package 65162-0065-87. 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 May 19, 2025. 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 solution 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)

About NDC 65162-065

What is NDC 65162-065?: 65162-065 is the product NDC for Sodium Oxybate, Sodium oxybate 500 mg/mL solution, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sodium Oxybate.
What is the active ingredient?: Sodium oxybate.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Oxybate?: 3 other product NDCs are listed under this name. See all Sodium Oxybate 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 Oxybate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
sodium oxybate	Sodium oxybate .5 g/mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-891	31722-0891-18
sodium oxybate	Sodium oxybate .5 g/mL	SolutionOral	XLCare Pharmaceuticals, Inc.	72865-349	72865-0349-18
sodium oxybate	Sodium oxybate .5 g/mL	SolutionOral	Hikma Pharmaceuticals USA Inc.	0054-9628	00054-9628-57