Metaxalone
- Product NDC
- 50090-3174
- 11-digit product format
- 500903174
- Labeler code
- 50090
- Product ID
- 50090-3174_f6443435-5d19-4d2e-83b9-f693aa74ea76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203695
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3174-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
| 50090-3174-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
| 50090-3174-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
| 50090-3174-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
| 50090-3174-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
| 50090-3174-5 | 2023-01-30 | C162847 | 48780-1 | f386c64a-38fc-0266-e053-dadaa90a7c1a | Metaxalone Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3174-0 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 50090-3174-1 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 50090-3174-2 | Metaxalone | 15 in 1 BOTTLE | TABLET | 15 | 3 | |
| 50090-3174-3 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | 3 | |
| 50090-3174-4 | Metaxalone | 10 in 1 BOTTLE | TABLET | 10 | 3 | |
| 50090-3174-5 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3174-0 | EA - Each | 50090-3174 | 65a98568-6abb-41b6-a027-24c9c38d5891 | 1 | 2019-05-02 |
| 50090-3174-1 | EA - Each | 50090-3174 | 7add86e8-1a8c-41db-a2df-f93ccd795d2c | 1 | 2019-09-05 |
| 50090-3174-2 | EA - Each | 50090-3174 | 7ab9ab1c-8a17-48e5-a3ff-ff8030fb57a0 | 1 | 2019-09-05 |
| 50090-3174-3 | EA - Each | 50090-3174 | 710a6766-2c39-4d13-9ab3-7c5c6f655446 | 1 | 2019-09-05 |
| 50090-3174-4 | EA - Each | 50090-3174 | 14f90a28-76c7-4264-aa09-b03a8fd24213 | 1 | 2019-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3174 | METAXALONE TABLET [A-S MEDICATION SOLUTIONS] | 3 | Legacy NDC, 6 package rows | 20190827_dbede7cf-c326-4e8c-a17d-2136f61c8c97.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | dbede7cf-c326-4e8c-a17d-2136f61c8c97 | 3 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | dbede7cf-c326-4e8c-a17d-2136f61c8c97 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-3174-0 | 50090317400 | 30 in 1 BOTTLE | Historical | |||||
| 50090-3174-1 | 50090317401 | 60 TABLET in 1 BOTTLE (50090-3174-1) | 60 tablet | 2017-10-16 | 0000-00-00 | No | No | Current |
| 50090-3174-2 | 50090317402 | 15 in 1 BOTTLE | Historical | |||||
| 50090-3174-3 | 50090317403 | 20 TABLET in 1 BOTTLE (50090-3174-3) | 20 tablet | 2017-11-22 | 0000-00-00 | No | No | Current |
| 50090-3174-4 | 50090317404 | 10 in 1 BOTTLE | Historical | |||||
| 50090-3174-5 | 50090317405 | 100 TABLET in 1 BOTTLE (50090-3174-5) | 100 tablet | 2019-08-15 | 0000-00-00 | No | No | Current |