Prescription drug · ANDA
Methadone Hydrochloride NDC 51991-002
Methadone hydrochloride 10 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Breckenridge Pharmaceutical Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-002-98 | 5199100029851991000298 | 1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASSMarketed from Dec 30, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Breckenridge Pharmaceutical IncNDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218252
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 51991-002_afbef7a8-b397-42e5-a208-b372f9cc0017SPL ID afbef7a8-b397-42e5-a208-b372f9cc0017SPL set ID 13541167-95f4-4cb9-9d7d-3c1aced5c5f6RxCUI 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
N451991000298followed by a unit qualifier and the quantityPackage 51991-0002-98. 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 opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS ), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone Hydrochlor…
Excerpt only. Read the full label for complete information.
About NDC 51991-002
- What is NDC 51991-002?
- 51991-002 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL injection, solution, listed with the FDA by Breckenridge Pharmaceutical 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?
- Breckenridge Pharmaceutical Inc, NDC labeler code 51991. 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 | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6266 | 00641-6266-01 |
| 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 |