Metaxalone
- Product NDC
- 53746-553
- 11-digit product format
- 537460553
- Labeler code
- 53746
- Product ID
- 53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA203399
- Marketing category
- ANDA
- Marketing start
- 2013-05-31
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- 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 | 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 |
|---|
| 53746-553-01 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 53746-553-05 | Metaxalone | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 53746-553-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-553 | METAXALONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230112_f06f2b96-3684-483c-89f7-6c9201fd4664.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 |
|---|
| 53746-553-01 | 53746055301 | 100 TABLET in 1 BOTTLE (53746-553-01) | 100 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |
| 53746-553-05 | 53746055305 | 500 TABLET in 1 BOTTLE (53746-553-05) | 500 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |
| 53746-553-30 | 53746055330 | 30 TABLET in 1 BOTTLE (53746-553-30) | 30 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |