Metaxalone
- Product NDC
- 50436-0449
- 11-digit product format
- 504360449
- Labeler code
- 50436
- Product ID
- 50436-0449_adf8aaaf-b108-4a7e-84c1-b2c3d8525780
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA203695
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-0449-1 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 50436-0449-2 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 50436-0449-3 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-0449 | METAXALONE TABLET [UNIT DOSE SERVICES] | 2 | Legacy NDC, 3 package rows | 20220524_6869a255-cc41-4127-a629-97f8d78e880c.zip |
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 |
|---|
| 50436-0449-1 | 50436044901 | 30 TABLET in 1 BOTTLE (50436-0449-1) | 30 tablet | 2022-03-01 | 0000-00-00 | No | No | Current |
| 50436-0449-2 | 50436044902 | 60 TABLET in 1 BOTTLE (50436-0449-2) | 60 tablet | 2022-03-01 | 0000-00-00 | No | No | Current |
| 50436-0449-3 | 50436044903 | 90 TABLET in 1 BOTTLE (50436-0449-3) | 90 tablet | 2022-03-01 | 0000-00-00 | No | No | Current |