WAYRILZ
- Product NDC
- 58468-0251
- 11-digit product format
- 584680251
- Labeler code
- 58468
- Product ID
- 58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rilzabrutinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA219685
- Marketing category
- NDA
- Marketing start
- 2025-08-29
- Substance
- RILZABRUTINIB
- Active strength
- 400 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- WAYRILZ
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RILZABRUTINIB | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NWN58M4F5T |
| Rxcui | 2722403, 2722409 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0251-0 | WAYRILZ | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 6 |
| 58468-0251-5 | WAYRILZ | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 6 |
| 58468-0251-6 | WAYRILZ | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 58468-0251-6 | WAYRILZ | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58468-0251-0 | 58468025100 | 28 in 1 BLISTER PACK | | | | | Historical |
| 58468-0251-5 | 58468025105 | 2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) | 2 blister pack | 2025-08-29 | No | No | Historical |
| 58468-0251-6 | 58468025106 | 1 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-08-29 | No | No | Historical |