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NDC 65649-0552-04 Relistor 8 mg/.4mL Details
Relistor 8 mg/.4mL
Relistor is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is METHYLNALTREXONE BROMIDE.
MedlinePlus Drug Summary
Methylnaltrexone injection is used to treat constipation caused by opioid (narcotic) pain medications in people with chronic (on-going) pain that is not caused by cancer but may be related to a previous cancer or cancer treatment. It is also used to treat constipation caused by opioid pain medications in people with an advanced illness or for active cancer pain. Methylnaltrexone injection is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the effects of opioid (narcotic) medications.
Related Packages: 65649-0552-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Methylnaltrexone Injection
Product Information
| NDC | 65649-0552 |
|---|---|
| Product ID | 65649-552_0c52697c-202f-6baa-e063-6294a90a2591 |
| Associated GPIs | 52580050102015 |
| GCN Sequence Number | 068483 |
| GCN Sequence Number Description | methylnaltrexone bromide SYRINGE 8 MG/0.4ML SUBCUT |
| HIC3 | H3Y |
| HIC3 Description | MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING |
| GCN | 31279 |
| HICL Sequence Number | 035611 |
| HICL Sequence Number Description | METHYLNALTREXONE BROMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Relistor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methylnaltrexone bromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/.4mL |
| Substance Name | METHYLNALTREXONE BROMIDE |
| Labeler Name | Salix Pharmaceuticals, Inc. |
| Pharmaceutical Class | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021964 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65649-0552-04 (65649055204)
| NDC Package Code | 65649-552-04 |
|---|---|
| Billing NDC | 65649055204 |
| Package | 7 BLISTER PACK in 1 CARTON (65649-552-04) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE |
| Marketing Start Date | 2008-04-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |