Metaxalone
- Product NDC
- 51655-171
- 11-digit product format
- 516550171
- Labeler code
- 51655
- Product ID
- 51655-171_4988edec-6f12-9584-e063-6394a90aaf35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA207466
- Marketing category
- ANDA
- Marketing start
- 2022-07-21
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-171-20 | Metaxalone | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 2 |
| 51655-171-52 | Metaxalone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-171 | METAXALONE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230315_f2b46d69-1c20-5ae9-e053-2a95a90a60a9.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 |
|---|
| 51655-171-20 | 51655017120 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-171-20) | 20 tablet | 2022-07-21 | No | No | Historical |
| 51655-171-52 | 51655017152 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-171-52) | 30 tablet | 2023-02-03 | No | No | Historical |