Metaxalone
- Product NDC
- 52959-596
- 11-digit product format
- 529590596
- Labeler code
- 52959
- Product ID
- 52959-596_96bd5ba7-4885-4069-976d-eb4949445264
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA013217
- Marketing category
- NDA
- Marketing start
- 2007-11-01
- 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
- 2018-12-31
- 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 |
|---|---|---|---|---|---|
| 52959-596-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-239b-f424-e053-dadaa90a57ce | METAXALONE TABLETS 800 mg |
| 52959-596-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-239b-f424-e053-dadaa90a57ce | METAXALONE TABLETS 800 mg |
| 52959-596-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-239b-f424-e053-dadaa90a57ce | METAXALONE TABLETS 800 mg |
| 52959-596-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-239b-f424-e053-dadaa90a57ce | METAXALONE TABLETS 800 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-596-15 | Metaxalone | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 52959-596-20 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 52959-596-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 52959-596-60 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-596-15 | EA - Each | 52959-596 | afb82983-ba52-4f32-b7f2-cfdfe6c75710 | 1 | 2012-07-24 |
| 52959-596-20 | EA - Each | 52959-596 | 5ebda117-ab73-4de6-81e6-c2c83fcb2912 | 1 | 2012-07-24 |
| 52959-596-30 | EA - Each | 52959-596 | 2313a481-db7a-4640-ab22-48e0adbd4aa6 | 1 | 2012-07-24 |
| 52959-596-60 | EA - Each | 52959-596 | 46773d4a-dca1-4da3-8b1e-6d32980ba354 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METAXALONE | ACTIVE INGREDIENT | 1NMA9J598Y | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| METAXALONE | ACTIVE MOIETY | 1NMA9J598Y | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| CALCIUM | INACTIVE INGREDIENT | SY7Q814VUP | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METAXALONE (METAXALONE) TABLET [H.J. HARKINS COMPANY, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351254 | metaxalone 800 MG Oral Tablet | PSN | 1c410d74-2c12-4a6b-854e-8a03b5bf2fbf | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | 1c410d74-2c12-4a6b-854e-8a03b5bf2fbf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-596-15 | 52959059615 | 15 in 1 BOTTLE | Historical |
| 52959-596-20 | 52959059620 | 20 in 1 BOTTLE | Historical |
| 52959-596-30 | 52959059630 | 30 in 1 BOTTLE | Historical |
| 52959-596-60 | 52959059660 | 60 in 1 BOTTLE | Historical |