NDC 68788-0881
Skelaxin
Metaxalone
Skelaxin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc. The primary component is Metaxalone.
| Product ID | 68788-0881_b22d36c8-d346-4853-a73e-fb653231ed3a |
| NDC | 68788-0881 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Skelaxin |
| Generic Name | Metaxalone |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2003-01-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA013217 |
| Labeler Name | Preferred Pharmaceuticals, Inc |
| Substance Name | METAXALONE |
| Active Ingredient Strength | 800 mg/1 |
| Pharm Classes | Centrally-mediated Muscle Relaxation [PE] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 68788-0881-6
60 TABLET in 1 BOTTLE (68788-0881-6)
| Marketing Start Date | 2003-01-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68788-0881-3 [68788088103]
Skelaxin TABLET
| Marketing Category | NDA |
| Application Number | NDA013217 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-01-30 |
| Inactivation Date | 2019-10-29 |
NDC 68788-0881-9 [68788088109]
Skelaxin TABLET
| Marketing Category | NDA |
| Application Number | NDA013217 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-01-30 |
| Inactivation Date | 2019-10-29 |
NDC 68788-0881-1 [68788088101]
Skelaxin TABLET
| Marketing Category | NDA |
| Application Number | NDA013217 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-01-30 |
| Inactivation Date | 2019-10-29 |
NDC 68788-0881-6 [68788088106]
Skelaxin TABLET
| Marketing Category | NDA |
| Application Number | NDA013217 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-01-30 |
| Inactivation Date | 2019-10-29 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| METAXALONE | 800 mg/1 |
OpenFDA Data
| SPL SET ID: | d8684144-6c2d-4664-943a-2d3d2b46b1fc |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Centrally-mediated Muscle Relaxation [PE]
NDC Crossover Matching brand name "Skelaxin" or generic name "Metaxalone"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 10544-524 | SKELAXIN | metaxalone |
| 21695-123 | Skelaxin | Metaxalone |
| 68788-0881 | Skelaxin | Skelaxin |
| 55289-736 | SKELAXIN | SKELAXIN |
| 60793-136 | SKELAXIN | SKELAXIN |
| 80425-0084 | Skelaxin | Skelaxin |
| 80425-0122 | Skelaxin | Skelaxin |
| 0115-1745 | Metaxalone | Metaxalone |
| 0115-1748 | Metaxalone | Metaxalone |
| 0185-0448 | Metaxalone | Metaxalone |
| 0276-0508 | Metaxalone | Metaxalone |
| 0527-1435 | Metaxalone | Metaxalone |
| 0591-2341 | Metaxalone | Metaxalone |
| 0904-6831 | Metaxalone | Metaxalone |
| 10544-002 | Metaxalone | Metaxalone |
| 10544-144 | Metaxalone | Metaxalone |
| 21695-585 | Metaxalone | Metaxalone |
| 33261-724 | Metaxalone | Metaxalone |
| 35356-570 | Metaxalone | Metaxalone |
| 42254-040 | Metaxalone | Metaxalone |
| 42291-587 | Metaxalone | Metaxalone |
| 43063-239 | Metaxalone | Metaxalone |
| 43063-581 | Metaxalone | Metaxalone |
| 45865-942 | Metaxalone | Metaxalone |
| 45865-985 | Metaxalone | Metaxalone |
| 50090-1182 | Metaxalone | Metaxalone |
| 50090-3174 | Metaxalone | Metaxalone |
| 50090-3297 | Metaxalone | Metaxalone |
| 50090-3650 | Metaxalone | Metaxalone |
| 50090-3670 | Metaxalone | Metaxalone |
Trademark Results [Skelaxin]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKELAXIN 72111057 0715343 Live/Registered |
A. H. Robins Company, Incorporated 1960-12-30 |
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