Metaxalone
- Product NDC
- 85766-011
- 11-digit product format
- 857660011
- Labeler code
- 85766
- Product ID
- 85766-011_49eed194-0dfa-5136-e063-6394a90a88e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sportpharm LLC
- 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
- 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#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-011-01 | 85766001101 | 100 TABLET in 1 BOTTLE (85766-011-01) | 100 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-12 | 85766001112 | 12 TABLET in 1 BOTTLE (85766-011-12) | 12 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-15 | 85766001115 | 15 TABLET in 1 BOTTLE (85766-011-15) | 15 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-20 | 85766001120 | 20 TABLET in 1 BOTTLE (85766-011-20) | 20 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-30 | 85766001130 | 30 TABLET in 1 BOTTLE (85766-011-30) | 30 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-60 | 85766001160 | 60 TABLET in 1 BOTTLE (85766-011-60) | 60 tablet | 2025-06-19 | No | No | Historical |
| 85766-011-90 | 85766001190 | 90 TABLET in 1 BOTTLE (85766-011-90) | 90 tablet | 2025-06-19 | No | No | Historical |