Sirolimus
- Product NDC
- 67877-748
- 11-digit product format
- 678770748
- Labeler code
- 67877
- Product ID
- 67877-748_b6349068-caf8-4f40-959d-cb9f1b8dd2be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA214753
- Marketing category
- ANDA
- Marketing start
- 2021-03-13
- Substance
- SIROLIMUS
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208, 360110, 905158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-748-01 | Sirolimus | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 67877-748-05 | Sirolimus | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 67877-748-30 | Sirolimus | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 67877-748-33 | Sirolimus | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 67877-748-38 | Sirolimus | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-748 | SIROLIMUS TABLET [ASCEND LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 5 package rows | 20230202_cdc49844-3e77-41d3-8287-b16d0c4742c5.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 |
|---|
| 67877-748-01 | 67877074801 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-748-01) | | 2021-03-13 | 0000-00-00 | No | No | Current |
| 67877-748-05 | 67877074805 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-748-05) | | 2021-03-13 | 0000-00-00 | No | No | Current |
| 67877-748-30 | 67877074830 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-748-30) | | 2021-03-13 | 0000-00-00 | No | No | Current |
| 67877-748-33 | 67877074833 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 67877-748-38 | 67877074838 | 100 BLISTER PACK in 1 CARTON (67877-748-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-748-33) | 100 blister pack | 2021-03-13 | 0000-00-00 | No | No | Current |