riluzole
- Product NDC
- 68462-381
- 11-digit product format
- 684620381
- Labeler code
- 68462
- Product ID
- 68462-381_e8a81e60-47b6-4097-9e49-48eb88e694f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- riluzole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091394
- Marketing category
- ANDA
- Marketing start
- 2013-06-18
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-381-10 | riluzole | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 68462-381-60 | riluzole | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RILUZOLE | ACTIVE INGREDIENT | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| RILUZOLE | ACTIVE MOIETY | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-381 | RILUZOLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240104_f1ce57e8-d3fe-422c-8724-3101c258898a.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 |
|---|
| 68462-381-10 | 68462038110 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10) | 2013-06-18 | 0000-00-00 | No | No | Current |
| 68462-381-60 | 68462038160 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60) | 2013-06-18 | 0000-00-00 | No | No | Current |