Home DailyMed 8f8cf9e8-d727-4142-bcbf-3fdeb213ec9f National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:14:32 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.