Home NDC 0407-2222 Visipaque
Product NDC 0407-2222
11-digit product format 004072222
Labeler code 0407
Product ID 0407-2222_3bf8b69f-3b64-4112-b08a-53bbf6dd57e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iodixanol
Dosage form INJECTION, SOLUTION
Route INTRAVASCULAR
Labeler GE Healthcare Inc.
Application NDA020351
Marketing category NDA
Marketing start 2002-12-13
Substance IODIXANOL
Active strength 270 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 6 · 348 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020351-001 VISIPAQUE 270 IODIXANOL 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 N020351-002 VISIPAQUE 320 IODIXANOL 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION AP RLD, RS 1996-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION RLD, RS 1996-03-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION RLD, RS 1996-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION RLD, RS 1996-03-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION RLD, RS 1996-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION RLD, RS 1996-03-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION RLD, RS 1996-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020351-001 VISIPAQUE 270 55% INJECTABLE / INJECTION RLD, RS 1996-03-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020351-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION RLD, RS 1996-03-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Visipaque
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IODIXANOL 270 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 0407-2222-01 Visipaque 50 mL in 1 VIAL INJECTION, SOLUTION 50 14 0407-2222-01 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-02 Visipaque 100 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 100 14 0407-2222-02 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-03 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-03 Visipaque 150 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 150 14 0407-2222-06 Visipaque 50 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 50 14 0407-2222-06 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-16 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-16 Visipaque 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 14 0407-2222-17 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-17 Visipaque 100 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 100 14 0407-2222-19 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-19 Visipaque 150 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 150 14 0407-2222-21 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-21 Visipaque 200 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 200 14 0407-2222-50 Visipaque 100 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 100 14 0407-2222-50 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-52 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-52 Visipaque 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 14 0407-2222-53 Visipaque 100 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 100 14 0407-2222-53 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-54 Visipaque 150 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 150 14 0407-2222-54 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-55 Visipaque 10 in 1 BOX INJECTION, SOLUTION 10 14 0407-2222-55 Visipaque 200 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 200 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Iodixanol ACTIVE INGREDIENT HW8W27HTXX VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Iodixanol ACTIVE MOIETY HW8W27HTXX VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Calcium Chloride INACTIVE INGREDIENT M4I0D6VV5M VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Edetate Calcium Disodium INACTIVE INGREDIENT 25IH6R4SGF VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Tromethamine INACTIVE INGREDIENT 023C2WHX2V VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 6 Iodixanol ACTIVE INGREDIENT HW8W27HTXX VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 Iodixanol ACTIVE MOIETY HW8W27HTXX VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 calcium chloride INACTIVE INGREDIENT M4I0D6VV5M VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 hydrochloric acid INACTIVE INGREDIENT QTT17582CB VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 sodium chloride INACTIVE INGREDIENT 451W47IQ8X VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4 tromethamine INACTIVE INGREDIENT 023C2WHX2V VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-2222 VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 15 Current NDC, Legacy NDC 20230515_2d964c13-88ad-43be-88d4-a3a7ea4d5b5e.zip 0407-2222 VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] 13 Current NDC, Legacy NDC, 26 package rows 20230506_e9d87b8c-7695-4c0f-8e81-000dedb5f66d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0407-2222-01 00407222201 50 mL in 1 VIAL 50 ml Historical 0407-2222-02 00407222202 100 mL in 1 BOTTLE, GLASS 100 ml Historical 0407-2222-03 00407222203 10 in 1 BOX Historical 0407-2222-06 00407222206 50 mL in 1 BOTTLE, GLASS 50 ml Historical 0407-2222-16 00407222216 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC 2002-12-13 0000-00-00 No No Current 0407-2222-17 00407222217 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC 2002-12-13 0000-00-00 No No Current 0407-2222-19 00407222219 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC 2002-12-13 0000-00-00 No No Current 0407-2222-21 00407222221 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-21) / 200 mL in 1 BOTTLE, PLASTIC 2002-12-13 0000-00-00 No No Current 0407-2222-50 00407222250 100 mL in 1 BOTTLE, GLASS 100 ml Historical 0407-2222-52 00407222252 10 in 1 BOX Historical 0407-2222-53 00407222253 100 mL in 1 BOTTLE, PLASTIC 100 ml Historical 0407-2222-54 00407222254 150 mL in 1 BOTTLE, PLASTIC 150 ml Historical 0407-2222-55 00407222255 10 in 1 BOX Historical