Home NDC 0078-1189 FABHALTA
Product NDC 0078-1189
11-digit product format 000781189
Labeler code 0078
Product ID 0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iptacopan
Dosage form CAPSULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA218276
Marketing category NDA
Marketing start 2023-12-05
Substance IPTACOPAN HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Complement Factor B Inhibitor [EPC], Complement Factor B 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 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 N218276-001 FABHALTA IPTACOPAN HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218276-001 10093663 2034-07-14 U-3980 2024-09-04 N218276-001 10093663 2034-07-14 U-4161 2024-09-04 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 N218276-001 12285422 2038-08-30 U-4181 2025-05-19 N218276-001 12384758 2041-05-17 U-3980 2025-08-20 N218276-001 12384758 2041-05-17 U-4161 2025-08-20 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 N218276-001 12453726 2041-07-15 U-4300 2025-11-04
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 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 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218276-001 FABHALTA EQ 200MG BASE CAPSULE / ORAL RLD, RS 2023-12-05 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 88 observed states.
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 N218276-001 10093663 2034-07-14 U-4161 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 12285422 2038-08-30 U-4181 2025-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 12384758 2041-05-17 U-3980 2025-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 12384758 2041-05-17 U-4161 2025-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218276-001 12453726 2041-07-15 U-4300 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 10093663 2034-07-14 U-4161 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 12285422 2038-08-30 U-4181 2025-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 12384758 2041-05-17 U-3980 2025-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 12384758 2041-05-17 U-4161 2025-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218276-001 12453726 2041-07-15 U-4300 2025-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218276-001 10093663 2034-07-14 U-4161 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 12285422 2038-08-30 U-4181 2025-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 11603363 2041-05-25 Drug substance, Drug product 2023-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218276-001 11951101 2041-07-15 U-3895 2024-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218276-001 10093663 2034-07-14 U-3980 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218276-001 9682968 2034-07-14 Drug substance, Drug product 2023-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218276-001 11723901 2038-08-30 U-3980 2024-09-04 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base FABHALTA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPTACOPAN HYDROCHLORIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XW5CK7C6YH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671074 Internal RxNorm lookup 2671080 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 0078-1189-20 FABHALTA 60 in 1 BOTTLE CAPSULE 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1189 FABHALTA (IPTACOPAN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION] 4 Current NDC, 1 package rows 20250323_a76b5845-6e21-4d3b-ad07-cd8df1b60bee.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FABHALTA IPTACOPAN Novartis Pharmaceuticals Corporation a76b5845-6e21-4d3b-ad07-cd8df1b60bee 2026-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218276 application number: NDA218276 ndc (product): 0078-1189
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0078-1189-20 00078118920 60 CAPSULE in 1 BOTTLE (0078-1189-20) 60 capsule 2023-12-05 No No Current