Riluzole
- Product NDC
- 67877-286
- 11-digit product format
- 678770286
- Labeler code
- 67877
- Product ID
- 67877-286_ab3e90af-a9b7-4a4c-bbd9-31739b8aec19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Riluzole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA204048
- Marketing category
- ANDA
- Marketing start
- 2016-03-31
- Substance
- RILUZOLE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Benzothiazole [EPC], Benzothiazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Riluzole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RILUZOLE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7LJ087RS6F |
| Rxcui | 199206 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-286 | RILUZOLE TABLET [ASCEND LABORATORIES, LLC] | 10 | Current NDC, Legacy NDC, 6 package rows | 20220511_dd432c13-389e-46b3-8891-0cf1a58800ff.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 |
|---|
| 67877-286-05 | 67877028605 | 500 TABLET in 1 BOTTLE (67877-286-05) | 500 tablet | 2016-03-31 | 0000-00-00 | No | No | Current |
| 67877-286-10 | 67877028610 | 1000 TABLET in 1 BOTTLE (67877-286-10) | 1000 tablet | 2016-03-31 | 0000-00-00 | No | No | Current |
| 67877-286-14 | 67877028614 | 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK | 10 blister pack | 2016-03-31 | 0000-00-00 | No | No | Current |
| 67877-286-60 | 67877028660 | 60 TABLET in 1 BOTTLE (67877-286-60) | 60 tablet | 2016-03-31 | 0000-00-00 | No | No | Current |
| 67877-286-90 | 67877028690 | 90 TABLET in 1 BOTTLE (67877-286-90) | 90 tablet | 2016-03-31 | 0000-00-00 | No | No | Current |