Home NDC 50474-350 KYGEVVI
Product NDC 50474-350
11-digit product format 504740350
Labeler code 50474
Product ID 50474-350_433f8057-35f8-f7e8-e063-6294a90a3ffd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxecitine and doxribtimine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler UCB, Inc.
Application NDA219792
Marketing category NDA
Marketing start 2026-03-01
Substance DOXECITINE; DOXRIBTIMINE
Active strength 2; 2 g/1; g/1
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 1 .
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 N219792-001 KYGEVVI DOXECITINE; DOXRIBTIMINE 2GM/PACKET;2GM/PACKET FOR SOLUTION / ORAL RLD, RS 2025-11-03
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219792-001 10471087 2036-08-07 U-4358 2025-12-16 N219792-001 11649259 2040-08-19 U-4358 Drug product 2025-12-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219792-001 NCE 2030-11-03
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 2026-02-19 14:30 UTC 2026-02 N219792-001 KYGEVVI 2GM/PACKET;2GM/PACKET FOR SOLUTION / ORAL RLD, RS 2025-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219792-001 KYGEVVI 2GM/PACKET;2GM/PACKET FOR SOLUTION / ORAL RLD, RS 2025-11-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219792-001 KYGEVVI 2GM/PACKET;2GM/PACKET FOR SOLUTION / ORAL RLD, RS 2025-11-03 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219792-001 10471087 2036-08-07 U-4358 2025-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219792-001 11649259 2040-08-19 U-4358 Drug product 2025-12-16 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219792-001 10471087 2036-08-07 U-4358 2025-12-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219792-001 11649259 2040-08-19 U-4358 Drug product 2025-12-16 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219792-001 NCE 2030-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219792-001 NCE 2030-11-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219792-001 NCE 2030-11-03 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base KYGEVVI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXECITINE 2 g/1 DOXRIBTIMINE 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0W860991D6 Internal UNII lookup VC2W18DGKR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2737535 Internal RxNorm lookup 2737541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50474-350-01 KYGEVVI 1 in 1 PACKET POWDER, FOR SOLUTION 1 3 50474-350-30 KYGEVVI 30 in 1 CARTON POWDER, FOR SOLUTION 30 3
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 Sample Exclude flag Status 50474-350-01 50474035001 1 in 1 PACKET Historical 50474-350-30 50474035030 30 PACKET in 1 CARTON (50474-350-30) / 1 POWDER, FOR SOLUTION in 1 PACKET (50474-350-01) 30 packet 2026-03-01 No No Current