Sirolimus
- Product NDC
- 13668-658
- 11-digit product format
- 136680658
- Labeler code
- 13668
- Product ID
- 13668-658_d4b251f6-5378-2fc1-e053-2a95a90a73bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Torrent pharmaceuticals limited
- Application
- ANDA215016
- Marketing category
- ANDA
- Marketing start
- 2021-12-27
- Marketing end
- 0000-00-00
- Substance
- SIROLIMUS
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13668-658-87 | 13668065887 | 1 CARTON in 1 KIT (13668-658-87) > 1 BOTTLE, GLASS in 1 CARTON > 60 mL in 1 BOTTLE, GLASS (13668-658-13) | 1 carton | 2021-12-27 | 0000-00-00 | No | No | Current |