NDC codes

FDA NDC Directory
Product NDC (as listed)0406-8725Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-8725Add 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
0406-8725-10004068725101000 mL in 1 BOTTLE, PLASTIC (0406-8725-10)Marketed from Mar 14, 1973

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)
Methadose Sugar-FreeSuffix: SUGAR-FREE
Generic name (nonproprietary)
methadone hydrochloride
Active ingredients
Methadone hydrochloride — 10 mg/mL
Dosage form
Concentrate
Route
Oral
Labeler
SpecGx LLC
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017116
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372SPL ID eac074c9-ea47-4a82-a4c3-1149c30bf372SPL set ID 808a9d0b-720b-4034-a862-5122ff514608RxCUI 991147, 991149UNII 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

N400406872510 followed by a unit qualifier and the quantity

Package 00406-8725-10. 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)

METHADOSE contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration ( 2.1 )] . METHADOSE is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). ( 1 ) Maintena…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017116

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

FDA NDC Directory listings under NDA 017116
ProductStrengthForm · routeLabelerProduct NDC
Methadosemethadone hydrochlorideMethadone hydrochloride 10 mg/mLConcentrateOralSpecGx LLC0406-0527

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