Prescription drug · NDA
Methadose Sugar-Free (methadone hydrochloride) NDC 0406-8725
Methadone hydrochloride 10 mg/mL · Concentrate · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-8725-10 | 00406872510 | 1000 mL in 1 BOTTLE, PLASTIC (0406-8725-10)Marketed from Mar 14, 1973 |
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)
- Methadose Sugar-FreeSuffix: SUGAR-FREE
- Generic name (nonproprietary)
- methadone hydrochloride
- Active ingredients
- Methadone hydrochloride — 10 mg/mL
- Dosage form
- Concentrate
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017116
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372SPL ID eac074c9-ea47-4a82-a4c3-1149c30bf372SPL set ID 808a9d0b-720b-4034-a862-5122ff514608RxCUI 991147, 991149UNII 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
N400406872510followed by a unit qualifier and the quantityPackage 00406-8725-10. 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)
METHADOSE contains 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 21 CFR, Title 42, Sec 8 [see Dosage and Administration ( 2.1 )] . METHADOSE is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). ( 1 ) Maintena…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017116
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 |
|---|---|---|---|---|
| Methadosemethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | SpecGx LLC | 0406-0527 |