hyftor

Generic: sirolimus

Labeler: nobelpharma america, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hyftor
Generic Name sirolimus
Labeler nobelpharma america, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

sirolimus 2 mg/g

Manufacturer
Nobelpharma America, LLC

Identifiers & Regulatory

Product NDC 73683-101
Product ID 73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213478
Listing Expiration 2026-12-31
Marketing Start 2022-03-23

Pharmacologic Class

Established (EPC)
mtor inhibitor immunosuppressant [epc] kinase inhibitor [epc]
Mechanism of Action
mtor inhibitors [moa] protein kinase inhibitors [moa]
Physiologic Effect
decreased immunologic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73683101
Hyphenated Format 73683-101

Supplemental Identifiers

RxCUI
2596864 2596869
UNII
W36ZG6FT64
NUI
N0000175550 N0000175625 N0000175624 N0000175605 N0000175076

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hyftor (source: ndc)
Generic Name sirolimus (source: ndc)
Application Number NDA213478 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE
source: ndc

Packages (1)

73683-101-10 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE

Ingredients (1)

sirolimus (2 mg/g)

Linked Drug Pages (1)

HYFTOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3cf7f2ef-f144-0632-e063-6394a90a9b9c", "openfda": {"nui": ["N0000175550", "N0000175625", "N0000175624", "N0000175605", "N0000175076"], "unii": ["W36ZG6FT64"], "rxcui": ["2596864", "2596869"], "spl_set_id": ["edb3ea90-5adc-48ec-99f5-ab963e302f18"], "pharm_class_pe": ["Decreased Immunologic Activity [PE]"], "pharm_class_epc": ["mTOR Inhibitor Immunosuppressant [EPC]", "Kinase Inhibitor [EPC]"], "pharm_class_moa": ["mTOR Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Nobelpharma America, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (73683-101-10)  / 10 g in 1 TUBE", "package_ndc": "73683-101-10", "marketing_start_date": "20220323"}], "brand_name": "HYFTOR", "product_id": "73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9c", "dosage_form": "GEL", "pharm_class": ["Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "73683-101", "generic_name": "sirolimus", "labeler_name": "Nobelpharma America, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYFTOR", "active_ingredients": [{"name": "SIROLIMUS", "strength": "2 mg/g"}], "application_number": "NDA213478", "marketing_category": "NDA", "marketing_start_date": "20220323", "listing_expiration_date": "20261231"}