Metaxalone
- Product NDC
- 50090-3650
- 11-digit product format
- 500903650
- Labeler code
- 50090
- Product ID
- 50090-3650_8d2d65ad-3146-4218-8373-539cf48d3fe2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metaxalone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-3650-0 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-1 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-2 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-3 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-4 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-5 | 2023-02-07 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
| 50090-3650-5 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0d4b-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use METAXALONE safely and effectively. See full prescribing information for METAXALONE. METAXALONE tablets, USP, for oral use Initial U.S. Approval: 1962 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3650 | METAXALONE TABLET [A-S MEDICATION SOLUTIONS] | 17 | Current NDC, Legacy NDC, 6 package rows | 20230918_d4caa7c6-afb5-43a2-ba38-cf30106b1d62.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3650-0 | 50090365000 | 30 TABLET in 1 BOTTLE (50090-3650-0) | 30 tablet | 2018-10-11 | 0000-00-00 | No | No | Current |
| 50090-3650-1 | 50090365001 | 60 TABLET in 1 BOTTLE (50090-3650-1) | 60 tablet | 2018-10-11 | 0000-00-00 | No | No | Current |
| 50090-3650-2 | 50090365002 | 15 TABLET in 1 BOTTLE, PLASTIC (50090-3650-2) | 15 tablet | 2016-11-22 | 0000-00-00 | No | No | Current |
| 50090-3650-3 | 50090365003 | 20 TABLET in 1 BOTTLE, PLASTIC (50090-3650-3) | 20 tablet | 2016-11-22 | 0000-00-00 | No | No | Current |
| 50090-3650-4 | 50090365004 | 10 TABLET in 1 BOTTLE, PLASTIC (50090-3650-4) | 10 tablet | 2016-11-22 | 0000-00-00 | No | No | Current |
| 50090-3650-5 | 50090365005 | 100 TABLET in 1 BOTTLE (50090-3650-5) | 100 tablet | 2018-10-18 | 0000-00-00 | No | No | Current |