Home NDC 70436-211 iopamidol
Product NDC 70436-211
11-digit product format 704360211
Labeler code 70436
Product ID 70436-211_5f077c99-86e3-a9d4-e063-6294a90a36a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iopamidol
Dosage form INJECTION, SOLUTION
Route INTRAVASCULAR
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA217134
Marketing category ANDA
Marketing start 2024-04-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217134-001 IOPAMIDOL IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 A217134-002 IOPAMIDOL IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 A217134-003 IOPAMIDOL IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 A217134-004 IOPAMIDOL IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09
Therapeutic equivalence codes# Current TE-code 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 2 · 77 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 2026-10-15 13:18:30 2026-09 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217134-001 IOPAMIDOL 41% INJECTABLE / INJECTION AP2 2023-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217134-002 IOPAMIDOL 51% INJECTABLE / INJECTION AP 2024-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217134-003 IOPAMIDOL 61% INJECTABLE / INJECTION AP 2024-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217134-004 IOPAMIDOL 76% INJECTABLE / INJECTION AP 2024-04-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 77 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 70436-211-37 iopamidol 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 3 70436-211-80 iopamidol 1 in 1 CARTON INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-211 IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20240420_69e9ab05-88f8-45f9-8bc1-ed33ab1385f0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70436-211-37 70436021137 50 mL in 1 VIAL, SINGLE-DOSE 50 ml Historical 70436-211-80 70436021180 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-211-80) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-211-37) 2024-04-15 No No Current