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NDC 00054-3553-44 Methadone Hydrochloride 10 mg/mL Details
Methadone Hydrochloride 10 mg/mL
Methadone Hydrochloride is a ORAL CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is METHADONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Methadone is used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. It 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: 00054-3553-44Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Methadone
Product Information
| NDC | 00054-3553 |
|---|---|
| Product ID | 0054-3553_92f6e14b-cfa0-4c55-bc9e-3dadbd80f598 |
| Associated GPIs | 65100050101310 |
| GCN Sequence Number | 004239 |
| GCN Sequence Number Description | methadone HCl ORAL CONC 10 MG/ML ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 16415 |
| HICL Sequence Number | 001745 |
| HICL Sequence Number Description | METHADONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Methadone Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methadone Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CONCENTRATE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | METHADONE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA089897 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3553-44 (00054355344)
| NDC Package Code | 0054-3553-44 |
|---|---|
| Billing NDC | 00054355344 |
| Package | 30 mL in 1 BOTTLE, DROPPER (0054-3553-44) |
| Marketing Start Date | 1988-09-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |