Prescription drug · ANDA
Methadone Hydrochloride NDC 0641-6266
Methadone hydrochloride 10 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6266-01 | 0064162660100641626601 | 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6266-01) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 12, 2025 |
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 — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218609
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-6266_821743df-67de-46a9-92c5-b530047a3192SPL ID 821743df-67de-46a9-92c5-b530047a3192SPL set ID 1a6dbcb0-68f2-4f8b-94ee-baa2aa296293RxCUI 864714UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641626601followed by a unit qualifier and the quantityPackage 00641-6266-01. 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 Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, (see WARNINGS ) reserve Methadone Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or …
Excerpt only. Read the full label for complete information.
About NDC 0641-6266
- What is NDC 0641-6266?
- 0641-6266 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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.
Related NDCs: other Methadone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-910 | 60687-0910-01 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-659 | 67877-0659-01 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-660 | 67877-0660-01 |
| Methadone Hydrochloride | Methadone hydrochloride 200 mg/20mL | InjectionIntravenous | Long Grove Pharmaceuticals, LLC | 81298-7500 | 81298-7500-01 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Breckenridge Pharmaceutical Inc | 51991-002 | 51991-0002-98 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | American Health Packaging | 60687-818 | 60687-0818-86 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7417 | 00904-7417-61 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-331 | 68094-0331-58 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | SpecGx LLC | 0406-4123 | 00406-4123-0300406-4123-10 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/5mL | SolutionOral | SpecGx LLC | 0406-6221 | 00406-6221-05 |