SIROLIMUS
- Product NDC
- 31722-316
- 11-digit product format
- 317220316
- Labeler code
- 31722
- Product ID
- 31722-316_27e377c2-1e6a-d4e2-e063-6394a90a2812
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA215080
- Marketing category
- ANDA
- Marketing start
- 2024-09-16
- 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 |
|---|
| 31722-316-31 | SIROLIMUS | 1 in 1 KIT | SOLUTION | 1 | | 1 |
| 31722-316-60 | SIROLIMUS | 60 mL in 1 BOTTLE, GLASS | SOLUTION | 60 | | 1 |
| 31722-316-60 | SIROLIMUS | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-316 | SIROLIMUS (SIROLIMUS) SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 3 package rows | 20241128_80269e86-3b04-44d0-9bff-7e7129e8ccb3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-316-31 | 31722031631 | 1 CARTON in 1 KIT (31722-316-31) / 1 BOTTLE, GLASS in 1 CARTON (31722-316-60) / 60 mL in 1 BOTTLE, GLASS | 1 carton | 2024-09-16 | No | No | Current |
| 31722-316-60 | 31722031660 | 60 mL in 1 BOTTLE, GLASS | 60 ml | | | | Historical |