Metaxalone
- Product NDC
- 71205-326
- 11-digit product format
- 712050326
- Labeler code
- 71205
- Product ID
- 71205-326_a4ec7535-0ff1-4a5f-a175-046a5f9cadfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203695
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metaxalone
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-326-20 | Metaxalone | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 71205-326-30 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 71205-326-60 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 71205-326-90 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-326 | METAXALONE TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240120_c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6.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 |
|---|
| 71205-326-20 | 71205032620 | 20 TABLET in 1 BOTTLE (71205-326-20) | 20 tablet | 2020-09-30 | 0000-00-00 | No | No | Current |
| 71205-326-30 | 71205032630 | 30 TABLET in 1 BOTTLE (71205-326-30) | 30 tablet | 2019-09-01 | 0000-00-00 | No | No | Current |
| 71205-326-60 | 71205032660 | 60 TABLET in 1 BOTTLE (71205-326-60) | 60 tablet | 2019-09-01 | 0000-00-00 | No | No | Current |
| 71205-326-90 | 71205032690 | 90 TABLET in 1 BOTTLE (71205-326-90) | 90 tablet | 2019-09-01 | 0000-00-00 | No | No | Current |