Sirolimus
- Product NDC
- 68084-915
- 11-digit product format
- 680840915
- Labeler code
- 68084
- Product ID
- 68084-915_3ccedad8-85eb-c609-e063-6294a90a7e2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sirolimus
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA201578
- Marketing category
- ANDA
- Marketing start
- 2015-11-05
- 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
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-915-25 | Sirolimus | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | | 9 |
| 68084-915-95 | Sirolimus | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-915 | SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240117_5df60452-2b16-4ce9-8c29-48798a59d718.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-915-25 | 68084091525 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25) / 1 TABLET in 1 BLISTER PACK (68084-915-95) | 30 blister pack | 2015-11-05 | 0000-00-00 | No | No | Current |
| 68084-915-95 | 68084091595 | 1 in 1 BLISTER PACK | | | | | | Historical |