Metaxalone
- Product NDC
- 50228-474
- 11-digit product format
- 502280474
- Labeler code
- 50228
- Product ID
- 50228-474_2fa7c2d7-03c0-4f7e-aa18-d586e157e177
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2020-04-30
- 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, 351254 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-474-10 | Metaxalone | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
| 50228-474-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-474 | METAXALONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240829_1cef46bb-e590-4a58-82e0-7cf1fc3836a5.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 |
|---|
| 50228-474-10 | 50228047410 | 1000 TABLET in 1 BOTTLE (50228-474-10) | 1000 tablet | 2020-04-30 | 0000-00-00 | No | No | Current |
| 50228-474-30 | 50228047430 | 30 TABLET in 1 BOTTLE (50228-474-30) | 30 tablet | 2020-04-30 | 0000-00-00 | No | No | Current |