Methadone Hydrochloride NDC 0406-6221

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-6221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-6221Add 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
0406-6221-05	00406622105	500 mL in 1 BOTTLE (0406-6221-05)Marketed from Jun 18, 2021

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): Methadone Hydrochloride
Generic name (nonproprietary): methadone hydrochloride
Active ingredients: Methadone hydrochloride — 10 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207537
Marketing start: Jun 18, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-6221_4e01f70c-6006-4f0d-9fc9-a50788fe3fd1SPL ID 4e01f70c-6006-4f0d-9fc9-a50788fe3fd1SPL set ID 5baef1bf-8bf0-429c-a4ce-1c93171f3f15RxCUI 864761, 864769UNII 229809935B
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

N400406622105 followed by a unit qualifier and the quantity

Package 00406-6221-05. 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 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone hydrochloride oral solution is indicated for the: Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. 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 methadone hydrochloride oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)