Prescription drug · ANDA
Methadone Hydrochloride NDC 17856-0392
Methadone hydrochloride 10 mg/mL · Concentrate · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0392-1 | 17856039201 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGEMarketed from May 20, 2024 | |
| 17856-0392-3 | 17856039203 | 72 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 | |
| 17856-0392-6 | 17856039206 | 1 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGEMarketed from May 30, 2025 | |
| 17856-0392-7 | 17856039207 | 5 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 | |
| 17856-0392-8 | 17856039208 | 1 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGEMarketed from May 30, 2025 | |
| 17856-0392-9 | 17856039209 | 1 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.
- 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
N417856039201followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 040180
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Hikma Pharmaceuticals USA | 0054-0392 |