Home NDC 80830-2467 Iohexol
Product NDC 80830-2467
11-digit product format 808302467
Labeler code 80830
Product ID 80830-2467_ff93b085-67bb-4fef-b6b7-37dd845171e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Iohexol
Dosage form INJECTION, SOLUTION
Route INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA217737
Marketing category ANDA
Marketing start 2025-11-13
Substance IOHEXOL
Active strength 300 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 43 .
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 A217737-001 IOHEXOL IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 A217737-002 IOHEXOL IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A217737-001 CGT 2026-07-26
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.
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 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217737-002 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217737-002 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-002 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A217737-001 CGT 2026-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217737-001 CGT 2026-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217737-001 CGT 2026-07-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-001 CGT 2026-07-26 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Iohexol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOHEXOL 300 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4419T9MX03 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 80830-2467-1 Iohexol 75 mL in 1 BOTTLE, PLASTIC INJECTION, SOLUTION 75 9 80830-2467-2 Iohexol 10 in 1 CARTON INJECTION, SOLUTION 10 9
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iohexol IOHEXOL Amneal Pharmaceuticals Private Limited ff9456ef-c45a-450d-9004-a684af2bcc59 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217737 application number: ANDA217737 ndc (product): 80830-2467
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80830-2467-1 80830246701 75 mL in 1 BOTTLE, PLASTIC 75 ml Historical 80830-2467-2 80830246702 10 BOTTLE, PLASTIC in 1 CARTON (80830-2467-2) / 75 mL in 1 BOTTLE, PLASTIC (80830-2467-1) 2025-11-13 No No Current