Metaxalone
- Product NDC
- 68001-485
- 11-digit product format
- 680010485
- Labeler code
- 68001
- Product ID
- 68001-485_38efd774-a6de-1f8c-e063-6394a90a93fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2021-05-31
- 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 |
|---|
| 68001-485-00 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-485 | METAXALONE TABLET [BLUEPOINT LABORATORIES] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240913_c91c0fb0-0b61-4e45-8bea-d0bf57ca7068.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 |
|---|
| 68001-485-00 | 68001048500 | 100 TABLET in 1 BOTTLE (68001-485-00) | 100 tablet | 2021-05-31 | 0000-00-00 | No | No | Current |