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NDC 61919-0832-72 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 DIRECT RX. 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: 61919-0832-72Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Metaxalone
Product Information
| NDC | 61919-0832 |
|---|---|
| Product ID | 61919-832_0e87d7eb-8c0a-f72b-e063-6394a90aed9c |
| 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 | DIRECT RX |
| Pharmaceutical Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204770 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 61919-0832-72 (61919083272)
| NDC Package Code | 61919-832-72 |
|---|---|
| Billing NDC | 61919083272 |
| Package | 120 TABLET in 1 BOTTLE (61919-832-72) |
| Marketing Start Date | 2020-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |