Metaxalone
- Product NDC
- 69097-998
- 11-digit product format
- 690970998
- Labeler code
- 69097
- Product ID
- 69097-998_ab6ad4e1-6b03-45c9-b4d0-59bda8e3b35d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- CIPLA USA INC.
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2023-06-12
- Substance
- METAXALONE
- Active strength
- 400 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
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 |
|---|
| 69097-998-07 | 69097099807 | 100 TABLET in 1 BOTTLE (69097-998-07) | 100 tablet | 2023-06-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METAXALONE TABLETS, USP | CIPLA USA INC. | ScieGen Pharmaceuticals, Inc. | 2023-06-08 | HUMAN PRESCRIPTION DRUG LABEL | 1 |