Methadone Hydrochloride NDC 0054-3555

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-3555Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-3555Add 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
0054-3555-63	00054355563	500 mL in 1 BOTTLE (0054-3555-63)Marketed from May 22, 1981

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 — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087393
Marketing start: May 22, 1981
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-3555_02c36c8d-ac85-4274-bf54-532c83f57396SPL ID 02c36c8d-ac85-4274-bf54-532c83f57396SPL set ID 8c363f90-c378-48ae-abbc-aeb25c9bf5cbRxCUI 864761, 864769UNII 229809935BUPC 0300543555631, 0300543556638
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

N400054355563 followed by a unit qualifier and the quantity

Package 00054-3555-63. 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 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone Hydrochloride Oral Solution is indicated for the: • 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 ( 5.2 )] , reserve opioid analgesics, including Methadone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • Met…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 087393

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

FDA NDC Directory listings under ANDA 087393
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-031
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-331
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-818