FDA.reportPublic FDA data

POTASSIUM IODIDE

Product NDC
75834-280
11-digit product format
758340280
Labeler code
75834
Product ID
75834-280_62e50e38-f41a-4dc9-96e8-37a7c677bec5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM IODIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-12-29
Substance
POTASSIUM IODIDE
Active strength
1 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM IODIDE1 g/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
312541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0bf9487-45d0-4fbc-a8dd-90f505355d14Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-280-08POTASSIUM IODIDE237 mL in 1 BOTTLESOLUTION2373
75834-280-30POTASSIUM IODIDE30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-280-08ML - Milliliter75834-28054ad86fa-7345-48d8-9ab7-9852f37daae012022-05-04
75834-280-30ML - Milliliter75834-2808aa1e526-672d-47d1-a0e4-6238b8af780a12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-280POTASSIUM IODIDE SOLUTION [NIVAGEN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20230224_b0bf9487-45d0-4fbc-a8dd-90f505355d14.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 IODIDENivagen Pharmaceuticals, Inc.b0bf9487-45d0-4fbc-a8dd-90f505355d142023-02-22Warnings, Adverse reactionsExact identifier
ndc (product): 75834-280

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312541potassium iodide 1 GM in 1 mL Oral SolutionPSN90cf3abb-c6d4-4004-8ae2-f528260a72f4100
312541potassium iodide 1000 MG/ML Oral SolutionSCD90cf3abb-c6d4-4004-8ae2-f528260a72f4100
312541K+ Iodide 1000 MG/ML Oral SolutionSY90cf3abb-c6d4-4004-8ae2-f528260a72f4100
312541Pot Iodide 1000 MG/ML Oral SolutionSY90cf3abb-c6d4-4004-8ae2-f528260a72f4100
312541potassium iodide 1 GM per 1 ML Oral SolutionSY90cf3abb-c6d4-4004-8ae2-f528260a72f4100
312541potassium iodide 1 GM in 1 mL Oral SolutionPSNb0bf9487-45d0-4fbc-a8dd-90f505355d143
312541potassium iodide 1000 MG/ML Oral SolutionSCDb0bf9487-45d0-4fbc-a8dd-90f505355d143
312541K+ Iodide 1000 MG/ML Oral SolutionSYb0bf9487-45d0-4fbc-a8dd-90f505355d143
312541Pot Iodide 1000 MG/ML Oral SolutionSYb0bf9487-45d0-4fbc-a8dd-90f505355d143
312541potassium iodide 1 GM per 1 ML Oral SolutionSYb0bf9487-45d0-4fbc-a8dd-90f505355d143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-280-0875834028008237 mL in 1 BOTTLE (75834-280-08) 237 ml2021-12-290000-00-00NoNoCurrent
75834-280-307583402803030 mL in 1 BOTTLE, WITH APPLICATOR (75834-280-30) 30 ml2021-12-290000-00-00NoNoCurrent