Sirolimus
- Product NDC
- 0904-7248
- 11-digit product format
- 009047248
- Labeler code
- 0904
- Product ID
- 0904-7248_6b65f460-e55e-4196-af44-b9dd0e293e76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA214753
- Marketing category
- ANDA
- Marketing start
- 2021-03-13
- 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
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7248-04 | Sirolimus | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 4 |
| 0904-7248-04 | Sirolimus | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7248 | SIROLIMUS TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240828_1bef7d8f-524b-4218-8fef-6c3f3628d33e.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 |
|---|
| 0904-7248-04 | 00904724804 | 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2022-06-21 | 0000-00-00 | No | No | Current |