Sirolimus
- Product NDC
- 70518-3546
- 11-digit product format
- 705183546
- Labeler code
- 70518
- Product ID
- 70518-3546_3ab2126f-36af-6239-e063-6394a90a38ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214753
- Marketing category
- ANDA
- Marketing start
- 2022-09-30
- Substance
- SIROLIMUS
- Active strength
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 905158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3546-0 | Sirolimus | 100 in 1 BOX | TABLET | 100 | | 4 |
| 70518-3546-1 | Sirolimus | 1 in 1 POUCH | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3546 | SIROLIMUS TABLET [REMEDYREPACK INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240116_74549ff2-74dc-449d-9a01-087260f9f8be.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 |
|---|
| 70518-3546-0 | 70518354600 | 100 POUCH in 1 BOX (70518-3546-0) / 1 TABLET in 1 POUCH (70518-3546-1) | 100 pouch | 2022-09-30 | 0000-00-00 | No | No | Current |
| 70518-3546-1 | 70518354601 | 1 in 1 POUCH | | | | | | Historical |