Home NDC 0270-1412 ISOVUE-M
Product NDC 0270-1412
11-digit product format 002701412
Labeler code 0270
Product ID 0270-1412_07cc86aa-255e-f459-c9c5-747f57811163
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IOPAMIDOL
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler Bracco Diagnostics Inc
Application NDA018735
Marketing category NDA
Marketing start 1985-12-31
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 2027-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base ISOVUE-M
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOPAMIDOL 612 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JR13W81H44 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 0270-1412-15 ISOVUE-M 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 10 0270-1412-15 ISOVUE-M 10 in 1 PACKAGE INJECTION, SOLUTION 10 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-1412 ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 8 Current NDC, Legacy NDC, 2 package rows 20221108_11e893d2-0183-4581-b908-c8b7302c7edb.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0270-1412-15 00270141215 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15) / 15 mL in 1 VIAL, SINGLE-DOSE 1985-12-31 0000-00-00 No No Current