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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metaxalone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METAXALONE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1NMA9J598Y |
| Rxcui | 197935 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-998-07 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-998 | METAXALONE TABLET [CIPLA USA INC.] | 1 | Current NDC, 1 package rows | 20230613_c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |