Sirolimus
- Product NDC
- 69238-1594
- 11-digit product format
- 692381594
- Labeler code
- 69238
- Product ID
- 69238-1594_864e5959-61c6-44ff-8fe6-7a2550ba0a85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIrolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA211212
- Marketing category
- ANDA
- Marketing start
- 2019-10-25
- Substance
- SIROLIMUS
- Active strength
- 1 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 314230 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1594-3 | Sirolimus | 1 in 1 KIT | SOLUTION | 1 | | 16 |
| 69238-1594-6 | Sirolimus | 1 in 1 CARTON | SOLUTION | 1 | | 16 |
| 69238-1594-6 | Sirolimus | 60 mL in 1 BOTTLE, GLASS | SOLUTION | 60 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1594 | SIROLIMUS SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] | 16 | Current NDC, Legacy NDC, 3 package rows | 20250216_a522b5e1-fe51-4eb8-9657-3b1d6af8dfd5.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 |
|---|
| 69238-1594-3 | 69238159403 | 1 CARTON in 1 KIT (69238-1594-3) / 1 BOTTLE, GLASS in 1 CARTON (69238-1594-6) / 60 mL in 1 BOTTLE, GLASS | 1 carton | 2019-10-25 | 0000-00-00 | No | No | Current |
| 69238-1594-6 | 69238159406 | 1 in 1 CARTON | | | | | | Historical |