FDA.reportPublic FDA data

ThyroSafe

Product NDC
50633-910
Requested package NDC
50633-910-20
11-digit product format
506330910
Labeler code
50633
Product ID
50633-910_4628b109-7ff2-cbf5-e063-6294a90a7933
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Iodide
Dosage form
TABLET
Route
ORAL
Labeler
BTG International Inc.
Application
ANDA076350
Marketing category
ANDA
Marketing start
2002-09-30
Substance
POTASSIUM IODIDE
Active strength
65 mg/1
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076350-001THYROSAFEPOTASSIUM IODIDE65MGTABLET / ORALRS2002-09-10
A076350-002THYROSAFEPOTASSIUM IODIDE130MGTABLET / ORAL2025-04-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076350-001THYROSAFE65MGTABLET / ORALRS2002-09-10a50c72e98297…
2026-08-01 22:54:322026-06A076350-002THYROSAFE130MGTABLET / ORAL2025-04-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThyroSafePOTASSIUM IODIDEBTG International Inc.47762f8f-30e2-445d-aaa1-e04479f8dd5b2025-12-17Boxed warning, WarningsExact identifier
application applno (ANDA): 076350
application number: ANDA076350
ndc (package): 50633-910-20
ndc (product): 50633-910
ndc11 (package): 50633091020
ThyrosafePOTASSIUM IODIDEBTG International Inc30387dc3-da14-1964-e063-6394a90afa4e2025-03-13Boxed warning, WarningsExact identifier
application applno (ANDA): 076350
application number: ANDA076350

Additional Listing Data#

Finished product
Yes
Brand name base
ThyroSafe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM IODIDE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1C4QK22F9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
430174Internal RxNorm lookup
1086474Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47762f8f-30e2-445d-aaa1-e04479f8dd5bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50633-910-20ThyroSafe160 in 1 CARTONTABLET1603
50633-910-20ThyroSafe20 in 1 BOXTABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50633-910THYROSAFE (POTASSIUM IODIDE) TABLET [BTG INTERNATIONAL INC.]1Current NDC, Legacy NDC, 2 package rows20220406_47762f8f-30e2-445d-aaa1-e04479f8dd5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
430174potassium iodide 65 MG Oral TabletPSN47762f8f-30e2-445d-aaa1-e04479f8dd5b3
1086474ThyroSafe 65 MG Oral TabletPSN47762f8f-30e2-445d-aaa1-e04479f8dd5b3
1086474potassium iodide 65 MG Oral Tablet [ThyroSafe]SBD47762f8f-30e2-445d-aaa1-e04479f8dd5b3
430174potassium iodide 65 MG Oral TabletSCD47762f8f-30e2-445d-aaa1-e04479f8dd5b3
430174K+ Iodide 65 MG Oral TabletSY47762f8f-30e2-445d-aaa1-e04479f8dd5b3
1086474K+ Iodide 65 MG Oral Tablet [ThyroSafe]SY47762f8f-30e2-445d-aaa1-e04479f8dd5b3
430174Pot Iodide 65 MG Oral TabletSY47762f8f-30e2-445d-aaa1-e04479f8dd5b3
1086474Pot Iodide 65 MG Oral Tablet [ThyroSafe]SY47762f8f-30e2-445d-aaa1-e04479f8dd5b3
1086474ThyroSafe 65 MG Oral TabletSY47762f8f-30e2-445d-aaa1-e04479f8dd5b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50633-910-2050633091020160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK160 box2002-09-300000-00-00NoNoCurrent