Metaxalone
- Product NDC
- 55700-494
- 11-digit product format
- 557000494
- Labeler code
- 55700
- Product ID
- 55700-494_f1dd5bd6-120d-44fd-8dc8-61f0e8569020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA204770
- Marketing category
- ANDA
- Marketing start
- 2016-11-22
- Marketing end
- 2027-02-28
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metaxalone
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 |
|---|
| 55700-494-21 | Metaxalone | 21 in 1 BOTTLE | TABLET | 21 | | 8 |
| 55700-494-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 55700-494-60 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 55700-494-90 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-494 | METAXALONE TABLET [QUALITY CARE PRODUCTS, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241219_f05bb280-6736-4215-be5b-0e5f7991cd87.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 |
|---|
| 55700-494-21 | 55700049421 | 21 in 1 BOTTLE | | | | | | Historical |
| 55700-494-30 | 55700049430 | 30 TABLET in 1 BOTTLE (55700-494-30) | 30 tablet | 2017-02-10 | 2027-02-28 | No | No | Current |
| 55700-494-60 | 55700049460 | 60 TABLET in 1 BOTTLE (55700-494-60) | 60 tablet | 2017-02-10 | 0000-00-00 | No | No | Current |
| 55700-494-90 | 55700049490 | 90 TABLET in 1 BOTTLE (55700-494-90) | 90 tablet | 2017-02-10 | 2026-09-30 | No | No | Current |