Metaxalone
- Product NDC
- 10544-144
- 11-digit product format
- 105440144
- Labeler code
- 10544
- Product ID
- 10544-144_1ec86d05-f8ad-684f-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA203399
- Marketing category
- ANDA
- Marketing start
- 2013-09-11
- Marketing end
- 0000-00-00
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-144-09 | Metaxalone | 9 in 1 BOTTLE | TABLET | 9 | | 3 |
| 10544-144-12 | Metaxalone | 12 in 1 BOTTLE | TABLET | 12 | | 3 |
| 10544-144-20 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 10544-144-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-144 | METAXALONE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 4 package rows | 20150902_117c6190-77a2-2036-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-144-09 | 10544014409 | 9 in 1 BOTTLE | Historical |
| 10544-144-12 | 10544014412 | 12 in 1 BOTTLE | Historical |
| 10544-144-20 | 10544014420 | 20 in 1 BOTTLE | Historical |
| 10544-144-30 | 10544014430 | 30 in 1 BOTTLE | Historical |