| Product NDC: | 68258-7100 | 
| Proprietary Name: | Metaxalone | 
| Non Proprietary Name: | Metaxalone | 
| Active Ingredient(s): | 800 mg/1 & nbsp; Metaxalone | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 68258-7100 | 
| Labeler Name: | Dispensing Solutions, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA013217 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20071101 | 
| Package NDC: | 68258-7100-1 | 
| Package Description: | 16 TABLET in 1 BOTTLE (68258-7100-1) | 
| NDC Code | 68258-7100-1 | 
| Proprietary Name | Metaxalone | 
| Package Description | 16 TABLET in 1 BOTTLE (68258-7100-1) | 
| Product NDC | 68258-7100 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Metaxalone | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20071101 | 
| Marketing Category Name | NDA | 
| Labeler Name | Dispensing Solutions, Inc. | 
| Substance Name | METAXALONE | 
| Strength Number | 800 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] |