POTASSIUM IODIDE

Product NDC
0178-0314
11-digit product format
001780314
Labeler code
0178
Product ID
0178-0314_47d4999c-1880-6c77-e063-6294a90afa06
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM IODIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Mission Pharmacal Company
Application
ANDA206211
Marketing category
ANDA
Marketing start
2016-05-15
Substance
POTASSIUM IODIDE
Active strength
65 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0178-0314-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0178-0314-309bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206211-001POTASSIUM IODIDEPOTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORAL2016-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206211-001POTASSIUM IODIDE65MG/MLSOLUTION / ORALRS2016-03-24e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM IODIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM IODIDE65 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9e02a48-8129-9076-78b2-db01750bd220Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0314-30POTASSIUM IODIDE1 in 1 CARTONSOLUTION15
0178-0314-30POTASSIUM IODIDE30 mL in 1 BOTTLE, DROPPERSOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0314-30ML - Milliliter0178-0314d3b24338-34dc-440e-ae8e-df9db53e894912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0314POTASSIUM IODIDE SOLUTION [MISSION PHARMACAL COMPANY]4Current NDC, Legacy NDC, 2 package rows20230111_d9e02a48-8129-9076-78b2-db01750bd220.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM IODIDEPOTASSIUM IODIDEMission Pharmacal Companyd9e02a48-8129-9076-78b2-db01750bd2202026-01-07WarningsExact identifier
application applno (ANDA): 206211
application number: ANDA206211
ndc (product): 0178-0314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242429potassium iodide 325 MG in 5 mL Oral SolutionPSNd9e02a48-8129-9076-78b2-db01750bd2205
242429potassium iodide 65 MG/ML Oral SolutionSCDd9e02a48-8129-9076-78b2-db01750bd2205
242429K+ Iodide 65 MG/ML Oral SolutionSYd9e02a48-8129-9076-78b2-db01750bd2205
242429Pot Iodide 65 MG/ML Oral SolutionSYd9e02a48-8129-9076-78b2-db01750bd2205
242429potassium iodide 325 MG per 5 ML Oral SolutionSYd9e02a48-8129-9076-78b2-db01750bd2205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0178-0314-30001780314301 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER2016-05-150000-00-00NoNoCurrent