Metaxalone
- Product NDC
- 45865-985
- 11-digit product format
- 458650985
- Labeler code
- 45865
- Product ID
- 45865-985_9af18dc9-fcef-fde1-e053-2995a90a4087
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- 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
- 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 |
|---|
| 45865-985-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 45865-985-90 | 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 |
|---|
| 45865-985 | METAXALONE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20191231_9af17dc7-04cd-de48-e053-2995a90a8709.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 |
|---|
| 45865-985-30 | 45865098530 | 30 TABLET in 1 BOTTLE (45865-985-30) | 30 tablet | 2019-12-11 | 0000-00-00 | No | No | Current |
| 45865-985-90 | 45865098590 | 90 TABLET in 1 BOTTLE (45865-985-90) | 90 tablet | 2019-12-11 | 0000-00-00 | No | No | Current |