RILUZOLE
- Product NDC
- 69076-200
- 11-digit product format
- 690760200
- Labeler code
- 69076
- Product ID
- 69076-200_50133916-0578-8080-e063-6394a90ac4b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RILUZOLE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA206045
- Marketing category
- ANDA
- Marketing start
- 2020-01-01
- 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 |
|---|
| 69076-200-60 | RILUZOLE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69076-200 | RILUZOLE TABLET, FILM COATED [QUINN PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 1 package rows | 20231004_ccead445-970c-46a1-9532-2848cc2aa3b6.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 |
|---|
| 69076-200-60 | 69076020060 | 60 TABLET, FILM COATED in 1 BOTTLE (69076-200-60) | 2020-01-01 | 0000-00-00 | No | No | Current |