NDC codes

FDA NDC Directory
Product NDC (as listed)0406-2540Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-2540Add 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
0406-2540-010040625400100406254001100 TABLET in 1 BOTTLE (0406-2540-01)Marketed from Jul 12, 2005

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 — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
SpecGx LLCNDC labeler code 0406
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077142
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0406-2540_44ccd094-d1de-4a5c-bad6-523572c67d5cSPL ID 44ccd094-d1de-4a5c-bad6-523572c67d5cSPL set ID 544483e6-6f9d-4371-9e93-313e54e0ea05RxCUI 864978, 864980UNII 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

N400406254001 followed by a unit qualifier and the quantity

Package 00406-2540-01. 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 for oral suspension contain 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 42 CFR 8.12 [see Dosage and Administration ( 2.1 )] . Methadone hydrochloride tablets for oral suspension are an opioid agonist indicated for the: Detoxification treatment o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0406-2540

What is NDC 0406-2540?
0406-2540 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 40 mg/1 tablet, listed with the FDA by SpecGx 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?
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
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

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