What is NDC 0406-4123?

0406-4123 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by SpecGx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

SpecGx LLC, NDC labeler code 0406. 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 0406-4123

NDC codes

FDA NDC Directory

Product NDC (as listed)0406-4123Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00406-4123Add 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
0406-4123-03	0040641230300406412303	1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03) / 30 mL in 1 BOTTLE, DROPPERMarketed from Jun 18, 2021
0406-4123-10	0040641231000406412310	1000 mL in 1 BOTTLE (0406-4123-10)Marketed from Jun 18, 2021

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: SpecGx LLCNDC labeler code 0406
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207368
Marketing start: Jun 18, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0406-4123_e7fe2ba9-a739-48a6-97bc-544be1ba4a74SPL ID e7fe2ba9-a739-48a6-97bc-544be1ba4a74SPL set ID 14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58RxCUI 991147UNII 229809935BUPC 0304064123034
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

N400406412303 followed by a unit qualifier and the quantity

Package 00406-4123-03. 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 Jul 29, 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 opioid a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0406-4123

What is NDC 0406-4123?: 0406-4123 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by SpecGx LLC. It has 2 package NDCs, 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?: SpecGx LLC, NDC labeler code 0406. 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/5mL	SolutionOral	SpecGx LLC	0406-6221	00406-6221-05

All 42 Methadone Hydrochloride NDCs