Prescription drug · ANDA
Methadone Hydrochloride NDC 72865-121
Methadone hydrochloride 10 mg/1 · Tablet · Oral · XLCare Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-121-01 | 72865012101 | 100 TABLET in 1 BOTTLE (72865-121-01)Marketed from Jan 3, 2019 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211228
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72865-121_639b24e8-927d-46ef-82f8-914a10528f21SPL ID 639b24e8-927d-46ef-82f8-914a10528f21SPL set ID 1a536622-dda3-41af-ab08-28e7c1bc9300RxCUI 864706, 864718UNII 229809935BUPC 0372865121016, 0372865120019
- 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
N472865012101followed by a unit qualifier and the quantityPackage 72865-0121-01. 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)
Methadone hydrochloride tablets are indicated for the: 1. 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 [see Warnings and Precautions (5.1)] , reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or opioid combination products) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211228
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/1 | TabletOral | American Health Packaging | 60687-910 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-120 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc | 31722-946 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc | 31722-947 |