Search by Drug Name or NDC
NDC 65162-0553-50 Metaxalone 800 mg/1 Details
Metaxalone 800 mg/1
Metaxalone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is METAXALONE.
MedlinePlus Drug Summary
Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries.
Related Packages: 65162-0553-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Metaxalone
Product Information
| NDC | 65162-0553 |
|---|---|
| Product ID | 65162-553_ede742ea-baad-4981-a912-230fa3c86d4f |
| Associated GPIs | 75100060000320 |
| GCN Sequence Number | 051112 |
| GCN Sequence Number Description | metaxalone TABLET 800 MG ORAL |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 91765 |
| HICL Sequence Number | 001945 |
| HICL Sequence Number Description | METAXALONE |
| Brand/Generic | Generic |
| Proprietary Name | Metaxalone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Metaxalone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 800 |
| Active Ingredient Units | mg/1 |
| Substance Name | METAXALONE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203399 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0553-50 (65162055350)
| NDC Package Code | 65162-553-50 |
|---|---|
| Billing NDC | 65162055350 |
| Package | 500 TABLET in 1 BOTTLE (65162-553-50) |
| Marketing Start Date | 2013-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |