Sirolimus
- Product NDC
- 55111-654
- 11-digit product format
- 551110654
- Labeler code
- 55111
- Product ID
- 55111-654_f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA201578
- Marketing category
- ANDA
- Marketing start
- 2014-10-27
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-654-01 | Sirolimus | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 55111-654-30 | Sirolimus | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-654 | SIROLIMUS TABLET [DR. REDDY'S LABORATORIES LIMITED] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240530_2e6130e5-fa94-dcf8-605c-817bf396e93d.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 |
|---|
| 55111-654-01 | 55111065401 | 100 TABLET in 1 BOTTLE (55111-654-01) | 100 tablet | 2014-10-27 | 0000-00-00 | No | No | Current |
| 55111-654-30 | 55111065430 | 30 TABLET in 1 BOTTLE (55111-654-30) | 30 tablet | 2014-10-27 | 0000-00-00 | No | No | Current |