Methadone Hydrochloride NDC 0054-3553

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-3553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-3553Add 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
0054-3553-44	00054355344	1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLEMarketed from Sep 6, 1988

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 Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089897
Marketing start: Sep 6, 1988
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-3553_54306250-31ce-4de4-8a25-4d8e711af582SPL ID 54306250-31ce-4de4-8a25-4d8e711af582SPL set ID d0e6a966-179a-45e0-8444-4c1b8523f8d2RxCUI 991147UNII 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

N400054355344 followed by a unit qualifier and the quantity

Package 00054-3553-44. 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 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone Hydrochloride Oral Concentrate ( Intensol ™) contains methadone, an opioid agonist indicated for the: • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use o Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions ( 5.5 )] , reserve Methadone Hydrochloride Intensol ™ for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffecti…

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	0054-0391