Methadone Hydrochloride NDC 68094-331

NDC codes

FDA NDC Directory

Product NDC (as listed)68094-331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68094-0331Add 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
68094-331-58	68094033158	50 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01)Marketed from Dec 29, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Precision Dose, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087393
Marketing start: Dec 29, 2023
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 68094-331_f323b0eb-5527-4874-aee6-ef6f49e5784bSPL ID f323b0eb-5527-4874-aee6-ef6f49e5784bSPL set ID e980d666-d74d-4358-a3b7-c6accb15eba6RxCUI 864761UNII 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

N468094033158 followed by a unit qualifier and the quantity

Package 68094-0331-58. 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 Jan 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone Hydrochloride Oral Solution is 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: 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 (5.2) ] , reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate t…

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	Hikma Pharmaceuticals USA Inc.	0054-3555
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	Precision Dose, Inc.	68094-031
Methadone Hydrochloride	Methadone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-818