Home NDC 71872-7369 OMNIPAQUE
Product NDC 71872-7369
11-digit product format 718727369
Labeler code 71872
Product ID 71872-7369_5088a472-5f1b-f365-e063-6394a90afb82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iohexol
Dosage form INJECTION, SOLUTION
Route INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler Medical Purchasing Solutions, LLC
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 387 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 N018956-001 OMNIPAQUE 180 38.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-002 OMNIPAQUE 240 51.8% SOLUTION / INJECTION, ORAL, RECTAL RLD, RS 1985-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-003 OMNIPAQUE 300 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP RLD, RS 1985-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-004 OMNIPAQUE 350 75.5% SOLUTION / INJECTION, ORAL AP RLD, RS 1985-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-005 OMNIPAQUE 140 30.2% INJECTABLE / INJECTION RLD, RS 1988-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-006 OMNIPAQUE 210 45.3% INJECTABLE / INJECTION 1989-06-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-007 OMNIPAQUE 70 15.1% SOLUTION / URETHRAL 1994-06-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-008 OMNIPAQUE 9 1.9% SOLUTION / ORAL RLD, RS 2018-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018956-009 OMNIPAQUE 12 2.6% SOLUTION / ORAL RLD, RS 2018-04-17 84e616aacf4f…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…
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 71872-7369-1 OMNIPAQUE 50 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 50 1 71872-7369-1 OMNIPAQUE 1 in 1 BAG INJECTION, SOLUTION 1 1
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 ndc (product): 71872-7369 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71872-7369-1 71872736901 1 BOTTLE, PLASTIC in 1 BAG (71872-7369-1) / 50 mL in 1 BOTTLE, PLASTIC 2026-03-26 No No Current