Home NDC 70436-124-33 iopamidol
Product NDC 70436-124
Requested package NDC 70436-124-33
11-digit product format 704360124
Labeler code 70436
Product ID 70436-124_16308b6e-8a2e-8431-e063-6294a90a986c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iopamidol
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler Slate Run Pharmaceuticals
Application ANDA215382
Marketing category ANDA
Marketing start 2023-07-20
Substance IOPAMIDOL
Active strength 408 mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215382-001 IOPAMIDOL IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 A215382-002 IOPAMIDOL IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27
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 2 · 46 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 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP1 2023-02-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215382-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP 2023-02-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215382-002 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2023-02-27 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base iopamidol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOPAMIDOL 408 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 70436-124-33 iopamidol 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 5 70436-124-35 iopamidol 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 5 70436-124-52 iopamidol 200 mL in 1 CARTON INJECTION, SOLUTION 200 5 70436-124-82 iopamidol 100 mL in 1 CARTON INJECTION, SOLUTION 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-124 IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS] 5 Current NDC, 4 package rows 20240418_0b9e0d24-c6ca-4e22-9422-936e9d475eaa.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70436-124-33 70436012433 10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33) 10 ml 2023-07-20 No No Current