Methadone Hydrochloride NDC 0406-5771

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-5771Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-5771Add 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
0406-5771-01	00406577101	100 TABLET in 1 BOTTLE (0406-5771-01)Marketed from Apr 27, 2004
0406-5771-23	00406577123	1 TABLET in 1 BLISTER PACK (0406-5771-23)Marketed from Apr 27, 2004
0406-5771-62	00406577162	100 TABLET in 1 BLISTER PACK (0406-5771-62)Marketed from Apr 27, 2004

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/1
Dosage form: Tablet
Route: Oral
Labeler: SpecGx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040517
Marketing start: Apr 27, 2004
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-5771_5084c093-f783-4043-8e6f-eb747a2c1d81SPL ID 5084c093-f783-4043-8e6f-eb747a2c1d81SPL set ID eddf7077-02fb-4771-9823-31984f4ff2bbRxCUI 864706, 864718UNII 229809935BUPC 0304065755012, 0304065771012
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

N400406577101 followed by a unit qualifier and the quantity

Package 00406-5771-01. 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 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone hydrochloride tablets are indicated for the: 1.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, reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain [see Warnings and Precautions ( 5.1 )] . Methadone hydrochl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040517

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

FDA NDC Directory listings under ANDA 040517
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 5 mg/1	TabletOral	SpecGx LLC	0406-5755