Home NDC 23155-326 Ibutilide Fumarate
Product NDC 23155-326
11-digit product format 231550326
Labeler code 23155
Product ID 23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibutilide Fumarate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA204146
Marketing category ANDA
Marketing start 2024-04-01
Substance IBUTILIDE FUMARATE
Active strength 1 mg/10mL
Pharmacologic classes Antiarrhythmic [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204146-001 IBUTILIDE FUMARATE IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204146-001 AP
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 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204146-001 IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP 2024-04-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ibutilide Fumarate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUTILIDE FUMARATE 1 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9L5X4M5L6I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979120 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 23155-326-31 Ibutilide Fumarate 1 in 1 CARTON INJECTION, SOLUTION 1 5 23155-326-31 Ibutilide Fumarate 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-326 IBUTILIDE FUMARATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 4 Current NDC, 2 package rows 20240403_0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0.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 Marketing start Sample Exclude flag Status 23155-326-31 23155032631 1 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS 2024-04-01 No No Current