Home NDC 0407-1416 OMNIPAQUE
Product NDC 0407-1416
11-digit product format 004071416
Labeler code 0407
Product ID 0407-1416_61f3e388-89bf-43d6-ad51-b620fff561fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iohexol
Dosage form SOLUTION
Route ORAL
Labeler GE Healthcare Inc.
Application NDA018956
Marketing category NDA
Marketing start 2018-04-27
Substance IOHEXOL
Active strength 12 mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018956-001 OMNIPAQUE 180 IOHEXOL 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 N018956-002 OMNIPAQUE 240 IOHEXOL 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 N018956-003 OMNIPAQUE 300 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP RLD, RS 1985-12-26 N018956-004 OMNIPAQUE 350 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP RLD, RS 1985-12-26 N018956-005 OMNIPAQUE 140 IOHEXOL 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 N018956-006 OMNIPAQUE 210 IOHEXOL 45.3% INJECTABLE / INJECTION 1989-06-30 N018956-007 OMNIPAQUE 70 IOHEXOL 15.1% SOLUTION / URETHRAL 1994-06-01 N018956-008 OMNIPAQUE 9 IOHEXOL 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 N018956-009 OMNIPAQUE 12 IOHEXOL 2.6% SOLUTION / ORAL RLD, RS 2018-04-17
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 10 · 378 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 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP RLD, RS 1985-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL AP RLD, RS 1985-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-005 OMNIPAQUE 140 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-006 OMNIPAQUE 210 45.3% INJECTABLE / INJECTION 1989-06-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-007 OMNIPAQUE 70 15.1% SOLUTION / URETHRAL 1994-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-008 OMNIPAQUE 9 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018956-009 OMNIPAQUE 12 2.6% SOLUTION / ORAL RLD, RS 2018-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP RLD, RS 1985-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL RLD, RS 1985-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-005 OMNIPAQUE 140 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-006 OMNIPAQUE 210 45.3% INJECTABLE / INJECTION 1989-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-007 OMNIPAQUE 70 15.1% SOLUTION / URETHRAL 1994-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-008 OMNIPAQUE 9 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018956-009 OMNIPAQUE 12 2.6% SOLUTION / ORAL RLD, RS 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP RLD, RS 1985-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL RLD, RS 1985-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-005 OMNIPAQUE 140 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-006 OMNIPAQUE 210 45.3% INJECTABLE / INJECTION 1989-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-007 OMNIPAQUE 70 15.1% SOLUTION / URETHRAL 1994-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-008 OMNIPAQUE 9 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018956-009 OMNIPAQUE 12 2.6% SOLUTION / ORAL RLD, RS 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL RLD, RS 1985-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-005 OMNIPAQUE 140 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-006 OMNIPAQUE 210 45.3% INJECTABLE / INJECTION 1989-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-007 OMNIPAQUE 70 15.1% SOLUTION / URETHRAL 1994-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-008 OMNIPAQUE 9 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018956-009 OMNIPAQUE 12 2.6% SOLUTION / ORAL RLD, RS 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL RLD, RS 1985-12-26 fd3edfee7708…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base OMNIPAQUE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOHEXOL 12 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4419T9MX03 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 0407-1416-12 OMNIPAQUE 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 19 0407-1416-12 OMNIPAQUE 10 in 1 BOX SOLUTION 10 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-1416 OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.] 18 Current NDC, Legacy NDC, 2 package rows 20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OMNIPAQUE IOHEXOL Medical Purchasing Solutions, LLC 5088be1d-a708-1cac-e063-6394a90a2aff 2026-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018956 application number: NDA018956 OMNIPAQUE IOHEXOL Medical Purchasing Solutions, LLC 508c42eb-f5e5-44f1-e063-6294a90a4d1f 2026-04-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018956 application number: NDA018956 OMNIPAQUE IOHEXOL GE Healthcare Inc. eee15ebe-d349-4497-acef-6abe7a8247fb 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018956 application number: NDA018956 ndc (product): 0407-1416
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0407-1416-12 00407141612 10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC 2018-04-27 0000-00-00 No No Current