Metaxalone
- Product NDC
- 72162-1083
- 11-digit product format
- 721621083
- Labeler code
- 72162
- Product ID
- 72162-1083_d6b5c3d1-07f5-48a7-b942-ae3895d65986
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204770
- Marketing category
- ANDA
- Marketing start
- 2016-11-22
- Substance
- METAXALONE
- Active strength
- 800 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 | 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 |
|---|
| 72162-1083-1 | Metaxalone | 100 in 1 BOTTLE | TABLET | 100 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1083 | METAXALONE TABLET [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20241115_a12304b7-6477-4518-8db5-898879c62caf.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 |
|---|
| 72162-1083-1 | 72162108301 | 100 TABLET in 1 BOTTLE (72162-1083-1) | 100 tablet | 2024-11-13 | No | No | Historical |