NDC codes

FDA NDC Directory
Product NDC (as listed)42806-318Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0318Add 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 NDC11-digit (billing)PackageCopy
42806-318-014280603180142806031801100 TABLET in 1 BOTTLE (42806-318-01)Marketed from Jun 11, 2018

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Epic Pharma, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090065
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 42806-318_43485290-cdfc-4126-a615-c52745fcd68bSPL ID 43485290-cdfc-4126-a615-c52745fcd68bSPL set ID 6da7501b-b881-4bc7-891a-74214a00a3acRxCUI 864706, 864718UNII 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

N442806031801 followed by a unit qualifier and the quantity

Package 42806-0318-01. 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 . 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 • 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 analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • Methad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-318

What is NDC 42806-318?
42806-318 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/1 tablet, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, 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?
Epic Pharma, LLC, NDC labeler code 42806. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methadone HydrochlorideMethadone hydrochloride 10 mg/1TabletOralAmerican Health Packaging60687-91060687-0910-01
Methadone HydrochlorideMethadone hydrochloride 5 mg/1TabletOralAscend Laboratories, LLC67877-65967877-0659-01
Methadone HydrochlorideMethadone hydrochloride 10 mg/1TabletOralAscend Laboratories, LLC67877-66067877-0660-01
Methadone HydrochlorideMethadone hydrochloride 200 mg/20mLInjectionIntravenousLong Grove Pharmaceuticals, LLC81298-750081298-7500-01
Methadone HydrochlorideMethadone hydrochloride 10 mg/mLInjectionIntramuscular, Intravenous, SubcutaneousHikma Pharmaceuticals USA Inc.0641-626600641-6266-01
Methadone HydrochlorideMethadone hydrochloride 10 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousBreckenridge Pharmaceutical Inc51991-00251991-0002-98
Methadone HydrochlorideMethadone hydrochloride 5 mg/5mLSolutionOralAmerican Health Packaging60687-81860687-0818-86
Methadone HydrochlorideMethadone hydrochloride 10 mg/1TabletOralMajor Pharmaceuticals0904-741700904-7417-61
Methadone HydrochlorideMethadone hydrochloride 5 mg/5mLSolutionOralPrecision Dose, Inc.68094-33168094-0331-58
Methadone HydrochlorideMethadone hydrochloride 10 mg/mLConcentrateOralSpecGx LLC0406-412300406-4123-0300406-4123-10

All 42 Methadone Hydrochloride NDCs

Other NDCs under ANDA 090065

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

FDA NDC Directory listings under ANDA 090065
ProductStrengthForm · routeLabelerProduct NDC
Methadone HydrochlorideMethadone hydrochloride 5 mg/1TabletOralEpic Pharma, LLC42806-317

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in