sirolimus
- Product NDC
- 65841-772
- 11-digit product format
- 658410772
- Labeler code
- 65841
- Product ID
- 65841-772_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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
openFDA Listing Details
- Product ID
- 65841-772_7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
- SPL ID
- 7e6e294d-cf29-40e2-91e1-9693fdcd6b6c
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- sirolimus
- Generic name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2023-02-16
- Marketing category
- ANDA
- Application number
- ANDA201676
- Pharmacologic classes
- Decreased Immunologic Activity [PE]; Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]; mTOR Inhibitor Immunosuppressant [EPC]; mTOR Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SIROLIMUS | 1 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208, 360110, 905158 |
| Spl Set Id | 82562b68-224d-482a-b399-a89b81d5eb31 |
| Manufacturer Name | Zydus Lifesciences Limited |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 65841-772-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-772-01) | 2023-02-16 | No |
| 65841-772-77 | 10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30) | 2023-02-16 | No |
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 |
|---|
| 65841-772-01 | 65841077201 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-772-01) | | 2023-02-16 | No | No | Historical |
| 65841-772-77 | 65841077277 | 10 BLISTER PACK in 1 CARTON (65841-772-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-772-30) | 10 blister pack | 2023-02-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SIROLIMUS TABLETS | Zydus Lifesciences Limited | 2023-09-27 | HUMAN PRESCRIPTION DRUG LABEL | 11 |