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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sirolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 905158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4449-0 | sirolimus | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 1 |
| 70518-4449-1 | sirolimus | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 70518-4449-1 | 70518444901 | 1 in 1 POUCH | | | | | Historical |