HYFTOR
- Product NDC
- 73683-101
- 11-digit product format
- 736830101
- Labeler code
- 73683
- Product ID
- 73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Nobelpharma America, LLC
- Application
- NDA213478
- Marketing category
- NDA
- Marketing start
- 2022-03-23
- Substance
- SIROLIMUS
- Active strength
- 2 mg/g
- 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
- HYFTOR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | 2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 2596864, 2596869 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73683-101-10 | HYFTOR | 1 in 1 CARTON | GEL | 1 | | 10 |
| 73683-101-10 | HYFTOR | 10 g in 1 TUBE | GEL | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73683-101 | HYFTOR (SIROLIMUS) GEL [NOBELPHARMA AMERICA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240112_edb3ea90-5adc-48ec-99f5-ab963e302f18.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 |
|---|
| 73683-101-10 | 73683010110 | 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE | 1 tube | 2022-03-23 | 0000-00-00 | No | No | Current |