NDC codes

FDA NDC Directory
Product NDC (as listed)0054-4538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-4538Add 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
0054-4538-2500054453825100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)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)
Diskets
Generic name (nonproprietary)
methadone hydrochloride
Active ingredients
Methadone hydrochloride — 40 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017058
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0054-4538_5d09b929-38f0-4c89-8bf5-31427a5cd393SPL ID 5d09b929-38f0-4c89-8bf5-31427a5cd393SPL set ID e6af84de-cbfc-4a3b-bd73-6bcf77337168RxCUI 864978, 1990745UNII 229809935BUPC 0300544538251
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

N400054453825 followed by a unit qualifier and the quantity

Package 00054-4538-25. 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)

DISKETS Dispersible Tablets contain 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 42 CFR 8.12 [see Dosage and Administration ( 2.1 )] . DISKETS Dispersible Tablets are an opioid agonist indicated for the: • Detoxification treatment of opioid addiction (heroin or other morphi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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