sirolimus
- Product NDC
- 68382-351
- 11-digit product format
- 683820351
- Labeler code
- 68382
- Product ID
- 68382-351_f54f3f24-5d0f-44a1-a4ca-03950954826f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA201676
- Marketing category
- ANDA
- Marketing start
- 2023-02-16
- Substance
- SIROLIMUS
- Active strength
- 1 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 |
|---|
| 68382-351-01 | 68382035101 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-351-01) | | 2023-02-16 | No | No | Historical |
| 68382-351-77 | 68382035177 | 10 BLISTER PACK in 1 CARTON (68382-351-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-351-30) | 10 blister pack | 2023-02-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| sirolimus | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-07-20 | HUMAN PRESCRIPTION DRUG LABEL | 16 |