NDC codes

FDA NDC Directory
Product NDC (as listed)17856-0392Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-0392Add 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
17856-0392-1178560392011785603920160 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGEMarketed from May 20, 2024
17856-0392-3178560392031785603920372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3) / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4)Marketed from May 20, 2024
17856-0392-617856039206178560392061 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGEMarketed from May 30, 2025
17856-0392-717856039207178560392075 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7) / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5)Marketed from May 20, 2024
17856-0392-817856039208178560392081 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGEMarketed from May 30, 2025
17856-0392-917856039209178560392091 SYRINGE in 1 BAG (17856-0392-9) / 2.5 mL in 1 SYRINGEMarketed from May 30, 2025

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/mL
Dosage form
Concentrate
Route
Oral
Labeler
ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040180
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 17856-0392_56433232-5399-e119-e063-6294a90a66dbSPL ID 56433232-5399-e119-e063-6294a90a66dbSPL set ID d7b30c78-c531-4dc5-9552-d68daa3210d1RxCUI 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

N417856039201 followed by a unit qualifier and the quantity

Package 17856-0392-01. 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)

INDICATIONS AND USAGE For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For 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 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 17856-0392

What is NDC 17856-0392?
17856-0392 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 6 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?
ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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 040180

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

FDA NDC Directory listings under ANDA 040180
ProductStrengthForm · routeLabelerProduct NDC
Methadone HydrochlorideMethadone hydrochloride 10 mg/mLConcentrateOralHikma Pharmaceuticals USA0054-0392

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