Home DailyMed 3f3c9bfe-2440-445e-b5eb-facef5e569f6 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 01:35:05 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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018735-001 ISOVUE-M 200 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 N018735-002 ISOVUE-300 IOPAMIDOL 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 N018735-003 ISOVUE-370 IOPAMIDOL 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 N018735-004 ISOVUE-M 300 IOPAMIDOL 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 N018735-005 ISOVUE-128 IOPAMIDOL 26% INJECTABLE / INJECTION 1986-10-21 N018735-006 ISOVUE-200 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 N018735-007 ISOVUE-250 IOPAMIDOL 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 8 · 301 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 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Observed Orange Book exclusivity history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.