sirolimus
- Product NDC
- 16714-188
- 11-digit product format
- 167140188
- Labeler code
- 16714
- Product ID
- 16714-188_433f1406-4cb9-4ae3-bdb9-2ff4c9011e5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA208691
- Marketing category
- ANDA
- Marketing start
- 2021-10-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sirolimus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208, 360110, 905158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-188-01 | sirolimus | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-188 | SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240103_ad39eb60-1fa0-4722-8ba1-523194921c2a.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 |
|---|
| 16714-188-01 | 16714018801 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-188-01) | 2021-10-18 | 0000-00-00 | No | No | Current |