Metaxalone
- Product NDC
- 45865-942
- 11-digit product format
- 458650942
- Labeler code
- 45865
- Product ID
- 45865-942_9adcfb31-33cf-6b70-e053-2995a90af3eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA204770
- Marketing category
- ANDA
- Marketing start
- 2016-11-22
- 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
- 2020-12-31
- 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 |
|---|
| 45865-942-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 45865-942-90 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-942 | METAXALONE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20191230_9add116a-cf29-7138-e053-2995a90a976e.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 |
|---|
| 45865-942-30 | 45865094230 | 30 TABLET in 1 BOTTLE (45865-942-30) | 30 tablet | 2018-12-12 | 0000-00-00 | No | No | Current |
| 45865-942-90 | 45865094290 | 90 TABLET in 1 BOTTLE (45865-942-90) | 90 tablet | 2018-12-12 | 0000-00-00 | No | No | Current |