Metaxalone
- Product NDC
- 80425-0580
- 11-digit product format
- 804250580
- Labeler code
- 80425
- Product ID
- 80425-0580_4face2dd-755d-77a0-e063-6294a90a32d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2026-04-17
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0580-1 | Metaxalone | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 80425-0580-2 | Metaxalone | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 80425-0580-3 | Metaxalone | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0580-1 | 80425058001 | 30 TABLET in 1 BOTTLE (80425-0580-1) | 30 tablet | 2026-04-17 | No | No | Historical |
| 80425-0580-2 | 80425058002 | 60 TABLET in 1 BOTTLE (80425-0580-2) | 60 tablet | 2026-04-17 | No | No | Historical |
| 80425-0580-3 | 80425058003 | 90 TABLET in 1 BOTTLE (80425-0580-3) | 90 tablet | 2026-04-17 | No | No | Historical |