Methadone Hydrochloride NDC 0904-7417

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7417Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7417Add 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
0904-7417-61	00904741761	100 BLISTER PACK in 1 CARTON (0904-7417-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 3, 2024

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/1
Dosage form: Tablet
Route: Oral
Labeler: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088109
Marketing start: Jan 3, 2024
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0904-7417_b783963f-af88-4437-82a0-c9d2264cda4aSPL ID b783963f-af88-4437-82a0-c9d2264cda4aSPL set ID db52fdc0-765a-4fad-a8f9-ef98c6e4b898RxCUI 864706UNII 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

N400904741761 followed by a unit qualifier and the quantity

Package 00904-7417-61. 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 16, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone Hydrochloride Tablets are indicated for the: 1. 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 2. 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 ( 5.1 )] , reserve opioid analgesics, including Methadone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. 3. Methadone Hy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 088109

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

FDA NDC Directory listings under ANDA 088109
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0709
Methadone Hydrochloride	Methadone hydrochloride 10 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0710