Home DailyMed d0fdff84-5e2c-4697-b285-eb78a788039d 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 02:44:11 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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.