Prescription drug · ANDA
Methadone Hydrochloride NDC 68094-331
Methadone hydrochloride 5 mg/5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-331-58 | 6809403315868094033158 | 50 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01)Marketed from Dec 29, 2023 |
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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087393
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68094-331_f323b0eb-5527-4874-aee6-ef6f49e5784bSPL ID f323b0eb-5527-4874-aee6-ef6f49e5784bSPL set ID e980d666-d74d-4358-a3b7-c6accb15eba6RxCUI 864761UNII 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
N468094033158followed by a unit qualifier and the quantityPackage 68094-0331-58. 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 Oral Solution is indicated for the: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.2) ] , reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate t…
Excerpt only. Read the full label for complete information.
About NDC 68094-331
- What is NDC 68094-331?
- 68094-331 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 5 mg/5mL solution, listed with the FDA by Precision Dose, 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?
- Precision Dose, Inc., NDC labeler code 68094. 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 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 |
Other NDCs under ANDA 087393
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 5 mg/5mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-3555 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | American Health Packaging | 60687-818 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-031 |