Riluzole
- Product NDC
- 0378-4145
- 11-digit product format
- 003784145
- Labeler code
- 0378
- Product ID
- 0378-4145_75a73f3c-36f0-482c-87fc-c5bab212d4e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- riluzole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203042
- Marketing category
- ANDA
- Marketing start
- 2013-07-22
- Marketing end
- 0000-00-00
- Substance
- RILUZOLE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Benzothiazole [EPC],Benzothiazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RILUZOLE | ACTIVE INGREDIENT | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| RILUZOLE | ACTIVE MOIETY | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4145 | RILUZOLE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 8 | Legacy NDC | 20250117_97457622-5727-4b07-9e72-edd784b2d76d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4145-91 | 00378414591 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4145-91) | 2013-07-22 | 0000-00-00 | No | No | Current |