Metaxalone
- Product NDC
- 42291-985
- 11-digit product format
- 422910985
- Labeler code
- 42291
- Product ID
- 42291-985_4c3ae8f1-8e81-9548-e063-6294a90a7a87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA203399
- Marketing category
- ANDA
- Marketing start
- 2026-03-04
- 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 |
|---|
| 42291-985-01 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 42291-985-50 | Metaxalone | 500 in 1 BOTTLE | TABLET | 500 | | 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 |
|---|
| 42291-985-01 | 42291098501 | 100 TABLET in 1 BOTTLE (42291-985-01) | 100 tablet | 2026-03-04 | No | No | Current |
| 42291-985-50 | 42291098550 | 500 TABLET in 1 BOTTLE (42291-985-50) | 500 tablet | 2026-03-04 | No | No | Current |