FYARRO
- Product NDC
- 80803-153
- 11-digit product format
- 808030153
- Labeler code
- 80803
- Product ID
- 80803-153_94544e08-d7c0-4154-aa40-46c5298c5528
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- Aadi Bioscience, Inc.
- Application
- NDA213312
- Marketing category
- NDA
- Marketing start
- 2021-12-06
- Substance
- SIROLIMUS
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FYARRO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 2586863, 2586868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80803-153-50 | FYARRO | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 80803-153-50 | FYARRO | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80803-153 | FYARRO (SIROLIMUS) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [AADI BIOSCIENCE] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241030_0f9bb784-53e2-46f9-a65d-1c6c2a230eaf.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 |
|---|
| 80803-153-50 | 80803015350 | 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE | 2021-12-06 | 0000-00-00 | No | No | Current |