Home NDC 50633-920 Thyrosafe
Product NDC 50633-920
11-digit product format 506330920
Labeler code 50633
Product ID 50633-920_30387dc3-da15-1964-e063-6394a90afa4e
Type HUMAN OTC DRUG
Nonproprietary name Potassium iodide
Dosage form TABLET
Route ORAL
Labeler BTG International Inc
Application ANDA076350
Marketing category ANDA
Marketing start 2025-11-26
Substance POTASSIUM IODIDE
Active strength 130 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076350-001 THYROSAFE POTASSIUM IODIDE 65MG TABLET / ORAL RS 2002-09-10 A076350-002 THYROSAFE POTASSIUM IODIDE 130MG TABLET / ORAL 2025-04-02
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 · 45 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 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076350-002 THYROSAFE 130MG TABLET / ORAL 2025-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076350-002 THYROSAFE 130MG TABLET / ORAL 2025-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076350-002 THYROSAFE 130MG TABLET / ORAL 2025-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076350-001 THYROSAFE 65MG TABLET / ORAL RS 2002-09-10 3a93d1ddd44b…
Additional Listing Data#
Finished product Yes
Brand name base Thyrosafe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM IODIDE 130 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1C4QK22F9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312539 Internal RxNorm lookup 2735395 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50633-920-20 Thyrosafe 20 in 1 BOX TABLET 20 1 50633-920-20 Thyrosafe 420 in 1 CARTON TABLET 420 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50633-920-20 50633092020 420 BOX in 1 CARTON (50633-920-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK 420 box 2025-11-26 No No Current