METAXALONE
- Product NDC
- 61919-832
- 11-digit product format
- 619190832
- Labeler code
- 61919
- Product ID
- 61919-832_47e15fc2-987b-4fa9-e063-6294a90adf51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METAXALONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA204770
- Marketing category
- ANDA
- Marketing start
- 2019-05-03
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METAXALONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METAXALONE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 351254 |
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 |
|---|
| 61919-832-90 | METAXALONE | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 61919-832-71 | METAXALONE | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 61919-832-72 | METAXALONE | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 61919-832-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 61919-832-60 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-832 | METAXALONE TABLET [DIRECT RX] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240110_49250bbf-fbfe-07cd-e054-00144ff88e88.zip |
| 61919-832 | METAXALONE TABLET [DIRECT RX] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220930_9b7b4fc3-3f38-db66-e053-2995a90aaadb.zip |
| 61919-832 | METAXALONE TABLET [DIRECT_RX] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190627_8c3bc0a2-5c93-e1d6-e053-2995a90a0b83.zip |
| 61919-832 | METAXALONE TABLET [DIRECT_RX] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190830_91432cd0-8404-8029-e053-2a95a90adc1b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-832-30 | 61919083230 | 30 TABLET in 1 BOTTLE (61919-832-30) | 30 tablet | 2019-06-26 | 0000-00-00 | No | No | Current |
| 61919-832-60 | 61919083260 | 60 TABLET in 1 BOTTLE (61919-832-60) | 60 tablet | 2019-08-29 | 0000-00-00 | No | No | Current |
| 61919-832-71 | 61919083271 | 100 TABLET in 1 BOTTLE (61919-832-71) | 100 tablet | 2020-01-06 | 0000-00-00 | No | No | Current |
| 61919-832-72 | 61919083272 | 120 TABLET in 1 BOTTLE (61919-832-72) | 120 tablet | 2020-01-06 | 0000-00-00 | No | No | Current |
| 61919-832-90 | 61919083290 | 90 TABLET in 1 BOTTLE (61919-832-90) | 90 tablet | 2019-05-03 | 0000-00-00 | No | No | Current |