What is NDC 0054-0391?

0054-0391 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by Hikma Pharmaceuticals USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA, NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methadone Hydrochloride?

41 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	0005403916800054039168	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 USANDC labeler code 0054
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)

About NDC 0054-0391

What is NDC 0054-0391?: 0054-0391 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by Hikma Pharmaceuticals USA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methadone Hydrochloride.
What is the active ingredient?: Methadone hydrochloride.
Who is the labeler?: Hikma Pharmaceuticals USA, NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methadone Hydrochloride?: 41 other product NDCs are listed under this name. See all Methadone Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methadone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methadone Hydrochloride	Methadone hydrochloride 10 mg/1	TabletOral	American Health Packaging	60687-910	60687-0910-01
Methadone Hydrochloride	Methadone hydrochloride 5 mg/1	TabletOral	Ascend Laboratories, LLC	67877-659	67877-0659-01
Methadone Hydrochloride	Methadone hydrochloride 10 mg/1	TabletOral	Ascend Laboratories, LLC	67877-660	67877-0660-01
Methadone Hydrochloride	Methadone hydrochloride 200 mg/20mL	InjectionIntravenous	Long Grove Pharmaceuticals, LLC	81298-7500	81298-7500-01
Methadone Hydrochloride	Methadone hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous, Subcutaneous	Hikma Pharmaceuticals USA Inc.	0641-6266	00641-6266-01
Methadone Hydrochloride	Methadone hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Breckenridge Pharmaceutical Inc	51991-002	51991-0002-98
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-818	60687-0818-86
Methadone Hydrochloride	Methadone hydrochloride 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7417	00904-7417-61
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-331	68094-0331-58
Methadone Hydrochloride	Methadone hydrochloride 10 mg/mL	ConcentrateOral	SpecGx LLC	0406-4123	00406-4123-0300406-4123-10

All 42 Methadone Hydrochloride NDCs

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