Oxycodone Hydrochloride NDC 0904-6678

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6678Add 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
0904-6678-40	00904667840	1 BOTTLE, PLASTIC in 1 CARTON (0904-6678-40) / 500 mL in 1 BOTTLE, PLASTICMarketed from Nov 23, 2016

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): Oxycodone Hydrochloride
Generic name (nonproprietary): oxycodone hydrochloride
Active ingredients: Oxycodone hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: MAJOR PHARMACEUTICALS
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207511
Marketing start: Nov 23, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0904-6678_7386412b-6260-4ac0-a1ce-6ce18d0421e0SPL ID 7386412b-6260-4ac0-a1ce-6ce18d0421e0SPL set ID e4fbf3fd-8755-4699-9a61-ba7fada0f93fRxCUI 1049604UNII C1ENJ2TE6CUPC 0309046678403
Pharmacologic class: Opioid Agonist

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

N400904667840 followed by a unit qualifier and the quantity

Package 00904-6678-40. 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 Feb 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2) ] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone hydrochloride oral solution is an opioid agonist indicated in adu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207511

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

FDA NDC Directory listings under ANDA 207511
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/5mL	SolutionOral	Bryant Ranch Prepack	63629-1174
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/5mL	SolutionOral	MAJOR PHARMACEUTICALS	0904-6828
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/5mL	SolutionOral	Eywa Pharma Inc	71930-022