Methadone Hydrochloride NDC 0054-0391

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0391Add 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
0054-0391-68	00054039168	1000 mL in 1 BOTTLE (0054-0391-68)Marketed from Jun 23, 2010

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/mL
Dosage form: Concentrate
Route: Oral
Labeler: Hikma Pharmaceuticals USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089897
Marketing start: Jun 23, 2010
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0391_6cc1b9b7-bfbc-478b-a572-05a802018bdaSPL ID 6cc1b9b7-bfbc-478b-a572-05a802018bdaSPL set ID e72841bf-364b-49b1-8e69-7e26ddcd2657RxCUI 991147UNII 229809935BUPC 0300540391683, 0300540392680
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

N400054039168 followed by a unit qualifier and the quantity

Package 00054-0391-68. 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 Mar 3, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone hydrochloride oral concentrate 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 )] . Methadone hydrochloride oral concentrate is an opioid agonist indicated for the: • Detoxification treatment of o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 089897

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

FDA NDC Directory listings under ANDA 089897
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 10 mg/mL	ConcentrateOral	Hikma Pharmaceuticals USA Inc.	0054-3553