Sirolimus
- Product NDC
- 16571-806
- 11-digit product format
- 165710806
- Labeler code
- 16571
- Product ID
- 16571-806_fff39157-a122-4e42-90f3-42d21ca85532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA215116
- Marketing category
- ANDA
- Marketing start
- 2025-07-15
- Substance
- SIROLIMUS
- Active strength
- 1 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sirolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 314230 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-806-06 | Sirolimus | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 16571-806-06 | Sirolimus | 1 in 1 KIT | SOLUTION | 1 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-806-06 | 16571080606 | 1 CARTON in 1 KIT (16571-806-06) / 1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS | 1 carton | 2025-07-15 | No | No | Historical |