Metaxalone
- Product NDC
- 0276-0508
- 11-digit product format
- 002760508
- Labeler code
- 0276
- Product ID
- 0276-0508_105c4456-677d-c76a-e063-6294a90a80a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Misemer Pharmaceuticals, Inc.
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- Substance
- METAXALONE
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 197935 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0276-0508-10 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0276-0508 | METAXALONE TABLET [MISEMER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240202_d0276e7b-a1c9-61f3-e053-2a95a90ae3aa.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 |
|---|
| 0276-0508-10 | 00276050810 | 100 TABLET in 1 BOTTLE (0276-0508-10) | 100 tablet | 2021-11-01 | 0000-00-00 | No | No | Current |