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NDC 68094-0331-58 Methadone Hydrochloride 5 mg/5mL Details
Methadone Hydrochloride 5 mg/5mL
Methadone Hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Precision Dose, Inc.. The primary component is METHADONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Methadone is used to relieve severe and persistent pain in people who are expected to need an opioid pain medication around the clock for a long time and who cannot be treated with other medications. Methadone should not be used to treat mild or moderate pain, short-term pain, or pain that can be controlled by medication that is taken as needed. Methadone also is used to prevent withdrawal symptoms in patients who were addicted to opiate drugs and are enrolled in treatment programs in order to stop taking or continue not taking the drugs. Methadone is in a class of medications called opiate (narcotic) analgesics. Methadone works to treat pain by changing the way the brain and nervous system respond to pain. It works to treat people who were addicted to opiate drugs by producing similar effects and preventing withdrawal symptoms in people who have stopped using these drugs.
Related Packages: 68094-0331-58Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Methadone
Product Information
| NDC | 68094-0331 |
|---|---|
| Product ID | 68094-331_7d77635d-662f-433e-9d39-6a71efb8b4be |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Methadone Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methadone Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | METHADONE HYDROCHLORIDE |
| Labeler Name | Precision Dose, Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA087393 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68094-0331-58 (68094033158)
| NDC Package Code | 68094-331-58 |
|---|---|
| Billing NDC | 68094033158 |
| Package | 50 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01) |
| Marketing Start Date | 2023-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |