NDC codes

FDA NDC Directory
Product NDC (as listed)66689-820Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66689-0820Add 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 NDC11-digit (billing)PackageCopy
66689-820-1066689082010100 TABLET in 1 BOTTLE (66689-820-10)Marketed from Nov 22, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040241
Marketing start
Marketing end
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 66689-820_ff2d657c-1e8a-4045-95e8-b02ed45a9404SPL ID ff2d657c-1e8a-4045-95e8-b02ed45a9404SPL set ID 4c8b541c-33e8-4969-b258-af150808d46eRxCUI 864706UNII 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

N466689082010 followed by a unit qualifier and the quantity

Package 66689-0820-10. 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 . 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 extended treatment with a daily opioid analgesic that cannot be adequately treated with alternative options, including immediate-release opioids Limitations of Use Because of the risks of addiction, abuse, and 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 analgesic treatment options (e.g., non-opioid analgesics or opioid combination products) are ineffective, not tol…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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