Riluzole
- Product NDC
- 42291-775
- 11-digit product format
- 422910775
- Labeler code
- 42291
- Product ID
- 42291-775_4c362542-247a-50f1-e063-6394a90a5065
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- riluzole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA206045
- Marketing category
- ANDA
- Marketing start
- 2020-10-07
- Substance
- RILUZOLE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Benzothiazole [EPC], Benzothiazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Riluzole
- Listing expiration
- 2027-12-31
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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-775-60 | Riluzole | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-775 | RILUZOLE TABLET, FILM COATED [AVKARE] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240111_b117b981-476c-f9b8-e053-2995a90aee5f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-775-60 | 42291077560 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-775-60) | 2020-10-07 | 0000-00-00 | No | No | Current |