Prescription drug · ANDA
Methadone Hydrochloride NDC 31722-946
Methadone hydrochloride 5 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-946-01 | 3172209460131722094601 | 100 TABLET in 1 BOTTLE (31722-946-01)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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, IncNDC labeler code 31722
- 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 31722-946_24878a39-232d-45f6-af1f-fbb00eb5d915SPL ID 24878a39-232d-45f6-af1f-fbb00eb5d915SPL set ID 8f4cf84e-165c-489d-a668-0f715053f196RxCUI 864706, 864718UNII 229809935BUPC 0331722947015, 0331722946018
- 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
N431722094601followed by a unit qualifier and the quantityPackage 31722-0946-01. 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 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 Precautions (5.1)] and persist over the course of therapy, reserve opioid analgesics, including methadone hydrochloride tablets, 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 hydrochlori…
Excerpt only. Read the full label for complete information.
About NDC 31722-946
- What is NDC 31722-946?
- 31722-946 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 5 mg/1 tablet, listed with the FDA by Camber Pharmaceuticals, 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?
- Camber Pharmaceuticals, Inc, NDC labeler code 31722. 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 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 |
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 | Camber Pharmaceuticals, Inc | 31722-947 |
| 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 10 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-121 |