Metaxalone
- Product NDC
- 68387-108
- 11-digit product format
- 683870108
- Labeler code
- 68387
- Product ID
- 68387-108_654dcfdc-4012-426e-bcd3-eb21b8e3ce2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA040486
- Marketing category
- ANDA
- Marketing start
- 2008-06-25
- 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 |
|---|
| 68387-108-30 | Metaxalone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 68387-108-60 | Metaxalone | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 68387-108-90 | Metaxalone | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68387-108 | METAXALONE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 3 package rows | 20100929_83cfbe48-4b69-445a-9c13-742ea345830e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68387-108-30 | 68387010830 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68387-108-60 | 68387010860 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 68387-108-90 | 68387010890 | 90 in 1 BOTTLE, PLASTIC | Historical |