Home NDC 65219-383-05 Iodixanol
Product NDC 65219-383
Requested package NDC 65219-383-05
11-digit product format 652190383
Labeler code 65219
Product ID 65219-383_1980ecbd-58c9-4176-af7f-af955bb0ad2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iodixanol
Dosage form INJECTION, SOLUTION
Route INTRAVASCULAR
Labeler FRESENIUS KABI USA, LLC
Application ANDA214271
Marketing category ANDA
Marketing start 2022-06-21
Substance IODIXANOL
Active strength 320 mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [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 43 .
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 A214271-001 IODIXANOL IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 A214271-002 IODIXANOL IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 2 · 62 observed 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 2026-09-14 22:38:34 2026-08 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214271-001 IODIXANOL 55% INJECTABLE / INJECTION AP 2022-05-19 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214271-002 IODIXANOL 65.2% INJECTABLE / INJECTION AP 2022-05-19 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Iodixanol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IODIXANOL 320 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HW8W27HTXX Internal UNII 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 65219-383-02 Iodixanol 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 5 65219-383-04 Iodixanol 100 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 100 5 65219-383-05 Iodixanol 10 in 1 BOX INJECTION, SOLUTION 10 5 65219-383-06 Iodixanol 150 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 150 5 65219-383-08 Iodixanol 200 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 200 5 65219-383-10 Iodixanol 10 in 1 BOX INJECTION, SOLUTION 10 5 65219-383-50 Iodixanol 10 in 1 BOX INJECTION, SOLUTION 10 5 65219-383-70 Iodixanol 10 in 1 BOX INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-383 IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 8 package rows 20230803_0fe89ea2-04f7-46c5-9c35-220d8c144a95.zip 65219-383 BL-C KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Current NDC, Legacy NDC 20250102_798f3bc6-d976-49a6-87a2-fd30c784fc50.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BL-C Kit BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE Asclemed USA, Inc. 798f3bc6-d976-49a6-87a2-fd30c784fc50 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 65219-383-05 ndc11 (package): 65219038305 Iodixanol IODIXANOL FRESENIUS KABI USA, LLC 0fe89ea2-04f7-46c5-9c35-220d8c144a95 2023-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214271 application number: ANDA214271 ndc (package): 65219-383-05 ndc (product): 65219-383 ndc11 (package): 65219038305
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65219-383-05 65219038305 10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) 2022-06-21 0000-00-00 No No Current