Metaxalone
- Product NDC
- 0904-6831
- 11-digit product format
- 009046831
- Labeler code
- 0904
- Product ID
- 0904-6831_6c542137-1ac8-4d4e-bca2-16ec8827d59e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- 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 |
|---|
| 0904-6831-04 | Metaxalone | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 0904-6831-04 | Metaxalone | 30 in 1 CARTON | TABLET | 30 | | 6 |
| 0904-6831-06 | Metaxalone | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 0904-6831-06 | Metaxalone | 50 in 1 CARTON | TABLET | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6831 | METAXALONE TABLET [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250308_8c1e10fe-0330-4bf8-a94d-aeed80f6aef1.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 |
|---|
| 0904-6831-04 | 00904683104 | 30 BLISTER PACK in 1 CARTON (0904-6831-04) / 1 TABLET in 1 BLISTER PACK | 30 blister pack | 2017-08-31 | 0000-00-00 | No | No | Current |
| 0904-6831-06 | 00904683106 | 50 BLISTER PACK in 1 CARTON (0904-6831-06) / 1 TABLET in 1 BLISTER PACK | 50 blister pack | 2017-08-31 | 0000-00-00 | No | No | Current |