Metaxalone
- Product NDC
- 0185-0448
- 11-digit product format
- 001850448
- Labeler code
- 0185
- Product ID
- 0185-0448_70380871-8424-43a0-a2d2-8834f1a3f718
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA040445
- Marketing category
- ANDA
- Marketing start
- 2010-03-31
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METAXALONE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0185-0448-01 | 00185044801 | 100 TABLET in 1 BOTTLE (0185-0448-01) | 100 tablet | 2010-03-31 | 0000-00-00 | No | No | Current |
| 0185-0448-10 | 00185044810 | 1000 TABLET in 1 BOTTLE (0185-0448-10) | 1000 tablet | 2010-03-31 | 0000-00-00 | No | No | Current |