What is NDC 71335-1360?

71335-1360 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-1360

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1360Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1360Add 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
71335-1360-0	7133513600071335136000	168 TABLET in 1 BOTTLE (71335-1360-0)Marketed from Sep 28, 2022
71335-1360-1	7133513600171335136001	15 TABLET in 1 BOTTLE (71335-1360-1)Marketed from Sep 28, 2022
71335-1360-2	7133513600271335136002	30 TABLET in 1 BOTTLE (71335-1360-2)Marketed from Oct 1, 2019
71335-1360-3	7133513600371335136003	90 TABLET in 1 BOTTLE (71335-1360-3)Marketed from Aug 14, 2020
71335-1360-4	7133513600471335136004	120 TABLET in 1 BOTTLE (71335-1360-4)Marketed from Sep 28, 2022
71335-1360-5	7133513600571335136005	180 TABLET in 1 BOTTLE (71335-1360-5)Marketed from Sep 28, 2022
71335-1360-6	7133513600671335136006	60 TABLET in 1 BOTTLE (71335-1360-6)Marketed from Sep 28, 2022
71335-1360-7	7133513600771335136007	28 TABLET in 1 BOTTLE (71335-1360-7)Marketed from Sep 28, 2022
71335-1360-8	7133513600871335136008	112 TABLET in 1 BOTTLE (71335-1360-8)Marketed from Sep 28, 2022
71335-1360-9	7133513600971335136009	56 TABLET in 1 BOTTLE (71335-1360-9)Marketed from Sep 28, 2022

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 Hydrochloride
Generic name (nonproprietary): methadone hydrochloride
Active ingredients: Methadone hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090635
Marketing start: Jan 16, 2012
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-1360_6f29db41-72f8-4eee-b826-d095449170f8SPL ID 6f29db41-72f8-4eee-b826-d095449170f8SPL set ID 7a8635fe-6183-4cda-9029-50e4e6dd5832RxCUI 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

N471335136000 followed by a unit qualifier and the quantity

Package 71335-1360-00. 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 Nov 6, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Methadone hydrochloride tablets, USP are indicated for the: 1. 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 (5.1)] , reserve methadone hydrochloride tablets, USP 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1360

What is NDC 71335-1360?: 71335-1360 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 090635

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

FDA NDC Directory listings under ANDA 090635
Product	Strength	Form · route	Labeler	Product NDC
Methadone Hydrochloride	Methadone hydrochloride 5 mg/1	TabletOral	Ascend Laboratories, LLC	67877-659
Methadone Hydrochloride	Methadone hydrochloride 10 mg/1	TabletOral	Ascend Laboratories, LLC	67877-660