sirolimus
- Product NDC
- 72205-099
- 11-digit product format
- 722050099
- Labeler code
- 72205
- Product ID
- 72205-099_5f3a03d8-3583-4214-baa9-4fe16d2628d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA216728
- Marketing category
- ANDA
- Marketing start
- 2023-01-19
- 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 |
|---|
| 72205-099-78 | sirolimus | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 72205-099-78 | sirolimus | 60 mL in 1 BOTTLE, GLASS | SOLUTION | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-099 | SIROLIMUS SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 3 | Current NDC, 2 package rows | 20250323_580c1ec1-c1f5-45f6-89b7-3be25c07a0e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-099-78 | 72205009978 | 1 BOTTLE, GLASS in 1 CARTON (72205-099-78) / 60 mL in 1 BOTTLE, GLASS | 2023-02-14 | No | No | Current |