Metaxalone
- Product NDC
- 50228-323
- 11-digit product format
- 502280323
- Labeler code
- 50228
- Product ID
- 50228-323_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
- 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe1c2a6-5488-f909-3872-734054eb745a | Product name | 5 | 20181231 |
| 776ba7f6-e5b0-442b-bd42-1fdfdfd821a4 | Product name | 1 | 20150615 |
| 68c52498-c9cb-48ab-a792-a4876149361e | Product name | 1 | 20150409 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50228-323-01 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 50228-323-05 | Metaxalone | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 50228-323-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 50228-323-01 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 50228-323-05 | Metaxalone | 500 in 1 BOTTLE | TABLET | 500 | 2 | |
| 50228-323-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50228-323-01 | EA - Each | 50228-323 | c6e69fca-9fed-428e-b2d6-13f8172949ae | 1 | 2021-06-02 |
| 50228-323-05 | EA - Each | 50228-323 | 59902ed7-908a-4ab0-bb98-7553dc58fa6d | 1 | 2021-06-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50228-323 | METAXALONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20210710_cec5b74b-8a5d-4474-8a70-ab44f5bf7bd4.zip |
| 50228-323 | METAXALONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240829_1cef46bb-e590-4a58-82e0-7cf1fc3836a5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | cec5b74b-8a5d-4474-8a70-ab44f5bf7bd4 | 3 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | cec5b74b-8a5d-4474-8a70-ab44f5bf7bd4 | 3 |
| 197935 | metaxalone 400 MG Oral Tablet | PSN | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2 |
| 351254 | metaxalone 800 MG Oral Tablet | PSN | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2 |
| 197935 | metaxalone 400 MG Oral Tablet | SCD | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 | 2 |
| 351254 | metaxalone 800 MG Oral Tablet | PSN | 4facde6f-1828-9138-e063-6294a90a1ec1 | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | PSN | fe82b33b-2a24-4477-91ca-b23e59156675 | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | 4facde6f-1828-9138-e063-6294a90a1ec1 | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | fe82b33b-2a24-4477-91ca-b23e59156675 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50228-323-01 | 50228032301 | 100 TABLET in 1 BOTTLE (50228-323-01) | 100 tablet | 2017-08-31 | 0000-00-00 | No | No | Current |
| 50228-323-05 | 50228032305 | 500 TABLET in 1 BOTTLE (50228-323-05) | 500 tablet | 2017-08-31 | 0000-00-00 | No | No | Current |
| 50228-323-30 | 50228032330 | 30 TABLET in 1 BOTTLE (50228-323-30) | 30 tablet | 2017-08-31 | 0000-00-00 | No | No | Current |