Home NDC 0407-1412 OMNIPAQUE
Product NDC 0407-1412
11-digit product format 004071412
Labeler code 0407
Product ID 0407-1412_61f3e388-89bf-43d6-ad51-b620fff561fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iohexol
Dosage form INJECTION, SOLUTION
Route INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler GE Healthcare Inc.
Application NDA018956
Marketing category NDA
Marketing start 1985-12-26
Substance IOHEXOL
Active strength 240 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 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 3 · 142 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 · 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 240 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 0407-1412-10 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-10 OMNIPAQUE 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 19 0407-1412-20 OMNIPAQUE 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION 20 19 0407-1412-20 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-27 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-27 OMNIPAQUE 150 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 150 19 0407-1412-28 OMNIPAQUE 200 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 200 19 0407-1412-28 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-29 OMNIPAQUE 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 19 0407-1412-29 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-30 OMNIPAQUE 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 19 0407-1412-30 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-33 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-33 OMNIPAQUE 100 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 100 19 0407-1412-34 OMNIPAQUE 150 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 150 19 0407-1412-34 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-35 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-35 OMNIPAQUE 200 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 200 19 0407-1412-49 OMNIPAQUE 150 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 150 19 0407-1412-49 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-50 OMNIPAQUE 50 mL in 1 VIAL, GLASS INJECTION, SOLUTION 50 19 0407-1412-50 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19 0407-1412-60 OMNIPAQUE 100 mL in 1 BOTTLE, GLASS INJECTION, SOLUTION 100 19 0407-1412-60 OMNIPAQUE 10 in 1 BOX INJECTION, SOLUTION 10 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-1412 OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.] 18 Current NDC, Legacy NDC, 24 package rows 20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip 0407-1412 BL-CONTRAST (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IOHEXOL, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 2 Current NDC, Legacy NDC 20240802_d498c395-dd95-4796-9030-ce95a9d985b8.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): 0407-1412
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0407-1412-10 00407141210 10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS 1985-12-26 0000-00-00 No No Current 0407-1412-20 00407141220 10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS 1985-12-26 0000-00-00 No No Current 0407-1412-27 00407141227 10 in 1 BOX Historical 0407-1412-28 00407141228 200 mL in 1 BOTTLE, PLASTIC 200 ml Historical 0407-1412-29 00407141229 50 mL in 1 BOTTLE, PLASTIC 50 ml Historical 0407-1412-30 00407141230 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-30) / 50 mL in 1 BOTTLE, PLASTIC 1985-12-26 0000-00-00 No No Current 0407-1412-33 00407141233 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-33) / 100 mL in 1 BOTTLE, PLASTIC 1985-12-26 0000-00-00 No No Current 0407-1412-34 00407141234 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-34) > 150 mL in 1 BOTTLE, PLASTIC 1985-12-26 0000-00-00 No No Current 0407-1412-35 00407141235 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-35) > 200 mL in 1 BOTTLE, PLASTIC 1985-12-26 0000-00-00 No No Current 0407-1412-38 00407141238 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-38) > 50 mL in 1 BOTTLE, PLASTIC 2005-08-11 0000-00-00 No No Current 0407-1412-39 00407141239 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-39) > 100 mL in 1 BOTTLE, PLASTIC 2005-08-11 0000-00-00 No No Current 0407-1412-40 00407141240 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-40) > 150 mL in 1 BOTTLE, PLASTIC 2005-08-11 0000-00-00 No No Current 0407-1412-49 00407141249 150 mL in 1 BOTTLE, GLASS 150 ml Historical 0407-1412-50 00407141250 50 mL in 1 VIAL, GLASS 50 ml Historical 0407-1412-60 00407141260 100 mL in 1 BOTTLE, GLASS 100 ml Historical 0407-1412-84 00407141284 10 BOTTLE in 1 BOX (0407-1412-84) > 100 mL in 1 BOTTLE 10 bottle 2005-08-11 0000-00-00 No No Current