Home NDC 76381-412 ISOVUE-M
Product NDC 76381-412
11-digit product format 763810412
Labeler code 76381
Product ID 76381-412_d038c2e6-5270-c2ac-9900-523456ef927c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IOPAMIDOL
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler BIPSO GmbH
Application NDA018735
Marketing category NDA
Marketing start 1985-12-31
Marketing end 0000-00-00
Substance IOPAMIDOL
Active strength 612 mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 287 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 2026-02-19 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-006 ISOVUE-200 41% INJECTABLE / INJECTION AP2 RLD, RS 1987-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018735-007 ISOVUE-250 51% INJECTABLE / INJECTION AP RLD, RS 1992-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018735-001 ISOVUE-M 200 41% INJECTABLE / INJECTION AP1 RLD, RS 1985-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018735-002 ISOVUE-300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018735-003 ISOVUE-370 76% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018735-004 ISOVUE-M 300 61% INJECTABLE / INJECTION AP RLD, RS 1985-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018735-005 ISOVUE-128 26% INJECTABLE / INJECTION 1986-10-21 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018735-002 I-975 2028-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-003 I-975 2028-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-006 I-975 2028-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018735-007 I-975 2028-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-002 I-975 2028-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-003 I-975 2028-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-006 I-975 2028-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018735-007 I-975 2028-10-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018735-002 I-975 2028-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018735-003 I-975 2028-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018735-006 I-975 2028-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N018735-007 I-975 2028-10-10 a50c72e98297…
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 · 2 matching rows.