Skelaxin
- Product NDC
- 21695-123
- 11-digit product format
- 216950123
- Labeler code
- 21695
- Product ID
- 21695-123_cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA013217
- Marketing category
- NDA
- Marketing start
- 1962-08-13
- 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 |
|---|---|---|---|---|---|
| 21695-123-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ca4-48b1-e053-8cdaa90a720a | SKELAXIN ® (Metaxalone) Tablets |
| 21695-123-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ca4-48b1-e053-8cdaa90a720a | SKELAXIN ® (Metaxalone) Tablets |
| 21695-123-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ca4-48b1-e053-8cdaa90a720a | SKELAXIN ® (Metaxalone) Tablets |
| 21695-123-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4ca4-48b1-e053-8cdaa90a720a | SKELAXIN ® (Metaxalone) Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-123-15 | Skelaxin | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 21695-123-30 | Skelaxin | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-123-60 | Skelaxin | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-123-90 | Skelaxin | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-123-15 | EA - Each | 21695-123 | cf49c99d-aa32-4448-91ff-8c5b2e4b6196 | 1 | 2012-07-24 |
| 21695-123-30 | EA - Each | 21695-123 | f94dfe51-dab9-46e1-a13f-c294fb0124c5 | 1 | 2012-07-24 |
| 21695-123-60 | EA - Each | 21695-123 | 17f077e5-3d50-43ff-b8f2-7bd3a5bf8f84 | 1 | 2012-07-24 |
| 21695-123-90 | EA - Each | 21695-123 | 4234f8a7-e779-429c-b1ed-ece735fcffcc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Metaxalone | ACTIVE INGREDIENT | 1NMA9J598Y | SKELAXIN (METAXALONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Metaxalone | ACTIVE MOIETY | 1NMA9J598Y | SKELAXIN (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 | cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb | 1 |
| 352277 | Skelaxin 800 MG Oral Tablet | PSN | cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb | 1 |
| 352277 | metaxalone 800 MG Oral Tablet [Skelaxin] | SBD | cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb | 1 |
| 351254 | metaxalone 800 MG Oral Tablet | SCD | cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb | 1 |
| 352277 | Skelaxin 800 MG Oral Tablet | SY | cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-123-15 | 21695012315 | 15 in 1 BOTTLE | Historical |
| 21695-123-30 | 21695012330 | 30 in 1 BOTTLE | Historical |
| 21695-123-60 | 21695012360 | 60 in 1 BOTTLE | Historical |
| 21695-123-90 | 21695012390 | 90 in 1 BOTTLE | Historical |