Metaxalone
- Product NDC
- 71205-426
- 11-digit product format
- 712050426
- Labeler code
- 71205
- Product ID
- 71205-426_8a05b052-c0ab-4cb1-af99-1d9c65024412
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA204770
- Marketing category
- ANDA
- Marketing start
- 2016-11-22
- Substance
- METAXALONE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71205-426_8a05b052-c0ab-4cb1-af99-1d9c65024412
- SPL ID
- 8a05b052-c0ab-4cb1-af99-1d9c65024412
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Metaxalone
- Generic name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2016-11-22
- Marketing category
- ANDA
- Application number
- ANDA204770
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| METAXALONE | 800 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 351254 |
| Spl Set Id | ee86f52c-fbf4-4882-bb7d-50220736fbb3 |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71205-426-14 | 14 TABLET in 1 BOTTLE (71205-426-14) | 2022-01-05 | No |
| 71205-426-20 | 20 TABLET in 1 BOTTLE (71205-426-20) | 2022-01-05 | No |
| 71205-426-30 | 30 TABLET in 1 BOTTLE (71205-426-30) | 2020-03-11 | No |
| 71205-426-60 | 60 TABLET in 1 BOTTLE (71205-426-60) | 2020-03-11 | No |
| 71205-426-90 | 90 TABLET in 1 BOTTLE (71205-426-90) | 2020-03-11 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1NMA9J598Y | METAXALONE | 1665-48-1 | METAXALONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-426-14 | 71205042614 | 14 TABLET in 1 BOTTLE (71205-426-14) | 14 tablet | 2022-01-05 | No | No | Historical |
| 71205-426-20 | 71205042620 | 20 TABLET in 1 BOTTLE (71205-426-20) | 20 tablet | 2022-01-05 | No | No | Historical |
| 71205-426-30 | 71205042630 | 30 TABLET in 1 BOTTLE (71205-426-30) | 30 tablet | 2020-03-11 | No | No | Historical |
| 71205-426-60 | 71205042660 | 60 TABLET in 1 BOTTLE (71205-426-60) | 60 tablet | 2020-03-11 | No | No | Historical |
| 71205-426-90 | 71205042690 | 90 TABLET in 1 BOTTLE (71205-426-90) | 90 tablet | 2020-03-11 | No | No | Historical |