NDC 72162-1085

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-1085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-1085Add 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
72162-1085-2	72162108502	30 mL in 1 BOTTLE, PLASTIC (72162-1085-2)Marketed from Oct 5, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Hydrocloride dye-free, sugar-free, unflavoredSuffix: dye-free, sugar-free, unflavored
Generic name (nonproprietary): methadone hydrochloride
Active ingredients: Methadone hydrochloride — 10 mg/mL
Dosage form: Concentrate
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212093
Marketing start: Nov 2, 2020
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 72162-1085_7dbaf38c-adfb-4540-add1-cf94e2e1885dSPL ID 7dbaf38c-adfb-4540-add1-cf94e2e1885dSPL set ID 714e5adb-bdce-4dff-99aa-4ac3a2f3a0feRxCUI 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

N472162108502 followed by a unit qualifier and the quantity

Package 72162-1085-02. 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 Apr 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone Hydrochloride 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 is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212093

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

FDA NDC Directory listings under ANDA 212093
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride	Methadone hydrochloride 10 mg/mL	ConcentrateOral	Atlantic Biologicals Corp.	17856-1927
Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride	Methadone hydrochloride 10 mg/mL	ConcentrateOral	Lannett Company, Inc.	0527-1927
Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride	Methadone hydrochloride 10 mg/mL	ConcentrateOral	Bryant Ranch Prepack	63629-2098

Methadone Hydrocloride dye-free, sugar-free, unflavored NDC 72162-1085