Sirolimus
- Product NDC
- 60505-6197
- 11-digit product format
- 605056197
- Labeler code
- 60505
- Product ID
- 60505-6197_5fb6d644-aae8-0bcc-d9ce-170dff1c4b44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIROLIMUS
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA211406
- Marketing category
- ANDA
- Marketing start
- 2020-05-20
- 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 |
|---|
| 60505-6197-2 | Sirolimus | 60 mL in 1 BOTTLE, GLASS | SOLUTION | 60 | | 6 |
| 60505-6197-2 | Sirolimus | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6197 | SIROLIMUS SOLUTION [APOTEX CORP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240809_9f64692d-2a18-ffcb-c572-0f218a71ca67.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6197-2 | 60505619702 | 1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS | 2020-05-20 | 2025-03-31 | No | No | Current |