sirolimus
- Product NDC
- 70518-4449
- 11-digit product format
- 705184449
- Labeler code
- 70518
- Product ID
- 70518-4449_3cbd5b5e-26f3-abc5-e063-6394a90a93eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208691
- Marketing category
- ANDA
- Marketing start
- 2025-08-19
- Substance
- SIROLIMUS
- Active strength
- .5 mg/1
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| W36ZG6FT64 | SIROLIMUS | 53123-88-9 | SIROLIMUS |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4449-0 | 70518444900 | 100 POUCH in 1 BOX (70518-4449-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4449-1) | 100 pouch | 2025-08-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| sirolimus | REMEDYREPACK INC. | 2025-08-19 | HUMAN PRESCRIPTION DRUG LABEL | 1 |