sirolimus
- Product NDC
- 68462-682
- 11-digit product format
- 684620682
- Labeler code
- 68462
- Product ID
- 68462-682_72132b30-e98c-4f0c-9fb7-ecb63ba18224
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA208691
- Marketing category
- ANDA
- Marketing start
- 2020-10-16
- Substance
- SIROLIMUS
- Active strength
- .5 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 | .5 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 |
|---|
| 68462-682-01 | 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 |
|---|
| 68462-682 | SIROLIMUS TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240104_57fb4d90-3ccb-4a69-af1e-53be83f7a504.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 |
|---|
| 68462-682-01 | 68462068201 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-682-01) | 2020-10-16 | 0000-00-00 | No | No | Current |