Methadone Hydrochloride NDC 64850-604

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-604Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0604Add 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
64850-604-01	64850060401	100 TABLET in 1 BOTTLE, PLASTIC (64850-604-01)Marketed from Aug 6, 2018

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): Methadone Hydrochloride
Generic name (nonproprietary): methadone hydrochloride
Active ingredients: Methadone hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Elite Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210484
Marketing start: Aug 6, 2018
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64850-604_6745a13f-b53a-4f0d-9c0a-bbef6343a8d3SPL ID 6745a13f-b53a-4f0d-9c0a-bbef6343a8d3SPL set ID d702d32b-98b1-412d-934c-1cd96af4b95aRxCUI 864706, 864718UNII 229809935BUPC 0364850603010, 0364850604017
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

N464850060401 followed by a unit qualifier and the quantity

Package 64850-0604-01. 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 Dec 8, 2025. 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 [see Warnings and Precautions (5.1) ] , 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. Methadone Hydrochl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210484

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

FDA NDC Directory listings under ANDA 210484
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 5 mg/1	TabletOral	Elite Laboratories, Inc.	64850-603