Home NDC 73683-101 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213478-001 HYFTOR SIROLIMUS 0.2% GEL / TOPICAL RLD, RS 2022-03-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213478-001 ODE-391 2029-03-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W36ZG6FT64 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2596864 Internal RxNorm lookup 2596869 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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