Metaxalone
- Product NDC
- 21695-585
- 11-digit product format
- 216950585
- Labeler code
- 21695
- Product ID
- 21695-585_21618014-77c1-4a35-acca-cd5678d7bb89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA040445
- Marketing category
- ANDA
- Marketing start
- 2010-03-31
- 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#
| 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 |
|---|---|---|---|---|---|
| 21695-585-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bb4-48b1-e053-8cdaa90a720a | Metaxalone Tablets, 800 mg |
| 21695-585-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bb4-48b1-e053-8cdaa90a720a | Metaxalone Tablets, 800 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-585-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-585-90 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-585-30 | EA - Each | 21695-585 | 521d05cb-042e-487e-b5d2-e10f04514b0b | 1 | 2012-07-24 |
| 21695-585-90 | EA - Each | 21695-585 | 2103f7df-8a71-4144-8519-6466aee57b58 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METAXALONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | 21618014-77c1-4a35-acca-cd5678d7bb89 | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | 21618014-77c1-4a35-acca-cd5678d7bb89 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-585-30 | 21695058530 | 30 in 1 BOTTLE | Historical |
| 21695-585-90 | 21695058590 | 90 in 1 BOTTLE | Historical |