Home NDC 58468-0347 Qfitlia
Product NDC 58468-0347
11-digit product format 584680347
Labeler code 58468
Product ID 58468-0347_1c225007-61f2-4c48-a25e-f08b8d356a59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fitusiran
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Genzyme Corporation
Application NDA219019
Marketing category NDA
Marketing start 2025-03-28
Substance FITUSIRAN
Active strength 20 mg/.2mL
Pharmacologic classes Antithrombin-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], Increased RNA Degradation [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219019-001 QFITLIA FITUSIRAN SODIUM EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 N219019-002 QFITLIA FITUSIRAN SODIUM EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 N219019-002 11091759 2036-12-07 U-4165 2025-04-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 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 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Qfitlia
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FITUSIRAN 20 mg/.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SV9W47ZLE1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2709452 Internal RxNorm lookup 2709458 Internal RxNorm lookup 2709461 Internal RxNorm lookup 2709464 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 58468-0347-1 Qfitlia 0.2 mL in 1 VIAL INJECTION, SOLUTION 0.2 6 58468-0347-1 Qfitlia 1 in 1 CARTON INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0347 QFITLIA (FITUSIRAN) INJECTION, SOLUTION [GENZYME CORPORATION] 3 Current NDC, 2 package rows 20250331_6dd2f8ac-6f90-4cbf-b197-97d74964135c.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 Sample Exclude flag Status 58468-0347-1 58468034701 1 VIAL in 1 CARTON (58468-0347-1) / .2 mL in 1 VIAL 1 vial 2025-03-28 No No Current