Sirolimus
- Product NDC
- 50268-718
- 11-digit product format
- 502680718
- Labeler code
- 50268
- Product ID
- 50268-718_4cb0eea7-6bbc-aef8-e063-6294a90a7887
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA201578
- Marketing category
- ANDA
- Marketing start
- 2018-04-23
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-718-11 | Sirolimus | 1 in 1 BLISTER PACK | TABLET | 1 | | 21 |
| 50268-718-13 | Sirolimus | 30 in 1 BOX | TABLET | 30 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-718 | SIROLIMUS TABLET [AVPAK] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240110_6a85ad01-8144-4d9c-e053-2991aa0a4f85.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-718-11 | 50268071811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-718-13 | 50268071813 | 30 BLISTER PACK in 1 BOX (50268-718-13) / 1 TABLET in 1 BLISTER PACK (50268-718-11) | 30 blister pack | 2018-04-23 | 0000-00-00 | No | No | Current |