Riluzole
- Product NDC
- 62756-538
- 11-digit product format
- 627560538
- Labeler code
- 62756
- Product ID
- 62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Riluzole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091417
- 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 |
|---|
| 62756-538-18 | Riluzole | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 10 |
| 62756-538-83 | Riluzole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 62756-538-86 | Riluzole | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
| 62756-538-88 | Riluzole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RILUZOLE | ACTIVE INGREDIENT | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| RILUZOLE | ACTIVE MOIETY | 7LJ087RS6F | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-538 | RILUZOLE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20200820_4c851be4-f0d0-4b24-baf9-427ddfc6f7b0.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 |
|---|
| 62756-538-18 | 62756053818 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18) | 2013-06-18 | 0000-00-00 | No | No | Current |
| 62756-538-83 | 62756053883 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-538-83) | 2013-06-18 | 0000-00-00 | No | No | Current |
| 62756-538-86 | 62756053886 | 60 TABLET, FILM COATED in 1 BOTTLE (62756-538-86) | 2013-06-18 | 0000-00-00 | No | No | Current |
| 62756-538-88 | 62756053888 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88) | 2013-06-18 | 0000-00-00 | No | No | Current |