Metaxalone
- Product NDC
- 68788-7018
- 11-digit product format
- 687887018
- Labeler code
- 68788
- Product ID
- 68788-7018_bb833f5d-c5dd-41de-afa3-c701da794415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA203695
- Marketing category
- ANDA
- Marketing start
- 2017-10-11
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metaxalone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METAXALONE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 351254 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-7018-0 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 68788-7018-1 | Metaxalone | 15 in 1 BOTTLE | TABLET | 15 | | 9 |
| 68788-7018-2 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | | 9 |
| 68788-7018-3 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 68788-7018-6 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7018 | METAXALONE TABLET [PREFERRED PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 5 package rows | 20240704_c0882edb-e2ad-470e-b26d-3c83b657abf9.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 |
|---|
| 68788-7018-0 | 68788701800 | 100 TABLET in 1 BOTTLE (68788-7018-0) | 100 tablet | 2017-10-11 | 0000-00-00 | No | No | Current |
| 68788-7018-1 | 68788701801 | 15 TABLET in 1 BOTTLE (68788-7018-1) | 15 tablet | 2017-10-11 | 0000-00-00 | No | No | Current |
| 68788-7018-2 | 68788701802 | 20 TABLET in 1 BOTTLE (68788-7018-2) | 20 tablet | 2017-10-11 | 0000-00-00 | No | No | Current |
| 68788-7018-3 | 68788701803 | 30 TABLET in 1 BOTTLE (68788-7018-3) | 30 tablet | 2017-10-11 | 0000-00-00 | No | No | Current |
| 68788-7018-6 | 68788701806 | 60 TABLET in 1 BOTTLE (68788-7018-6) | 60 tablet | 2017-10-11 | 0000-00-00 | No | No | Current |