Home NDC 69208-000 Sodium Iodide I-131
Product NDC 69208-000
11-digit product format 692080000
Labeler code 69208
Product ID 69208-000_490fdcc0-a035-b6f8-e063-6394a90a28a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Iodide I-131
Dosage form KIT
Route ORAL
Labeler Radnostix, Inc.
Application ANDA209166
Marketing category ANDA
Marketing start 2020-03-16
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209166-001 SODIUM IODIDE I 131 SODIUM IODIDE I-131 250-1000mCi SOLUTION / ORAL AA 2020-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209166-001 AA
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 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209166-001 SODIUM IODIDE I 131 250-1000mCi SOLUTION / ORAL AA 2020-02-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 Sodium Iodide I-131
Listing expiration 2027-12-31 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 69208-000-00 Sodium Iodide I-131 1 in 1 BOX KIT 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69208-000 SODIUM IODIDE I-131 KIT [INTERNATIONAL ISOTOPES INC] 7 Current NDC, Legacy NDC, 1 package rows 20240110_380e8e26-0625-4233-b36e-afb9f66e8a77.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 Marketing end Sample Exclude flag Status 69208-000-00 69208000000 1 KIT in 1 BOX (69208-000-00) * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15) 1 kit 2020-03-16 0000-00-00 No No Current