FDA.reportPublic FDA data

iopamidol

Product NDC
70436-127
11-digit product format
704360127
Labeler code
70436
Product ID
70436-127_3a1c5a58-814e-8d80-e063-6394a90ac71d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
iopamidol
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217134
Marketing category
ANDA
Marketing start
2024-04-15
Substance
IOPAMIDOL
Active strength
755 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOPAMIDOL755 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJR13W81H44

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
10141263-39cb-493e-b682-37b22a8d146dProduct name220250625
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-127-37iopamidol50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION503
70436-127-39iopamidol75 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION753
70436-127-40iopamidol100 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1003
70436-127-52iopamidol10 in 1 CARTONINJECTION, SOLUTION103
70436-127-62iopamidol10 in 1 CARTONINJECTION, SOLUTION103
70436-127-82iopamidol10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-127-40ML - Milliliter70436-127a9f17a65-7cde-4b0d-a22a-f3970f4cb13e12024-08-12
70436-127-82ML - Milliliter70436-12750f4d935-4e5e-4c82-aec2-477840b8be6312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-127IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 6 package rows20240420_69e9ab05-88f8-45f9-8bc1-ed33ab1385f0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-127-377043601273750 mL in 1 VIAL, SINGLE-DOSE50 mlHistorical
70436-127-397043601273975 mL in 1 VIAL, SINGLE-DOSE75 mlHistorical
70436-127-4070436012740100 mL in 1 VIAL, SINGLE-DOSE100 mlHistorical
70436-127-527043601275210 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-52) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-127-37) 2024-04-15NoNoHistorical
70436-127-627043601276210 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-62) / 75 mL in 1 VIAL, SINGLE-DOSE (70436-127-39) 2024-04-15NoNoHistorical
70436-127-827043601278210 VIAL, SINGLE-DOSE in 1 CARTON (70436-127-82) / 100 mL in 1 VIAL, SINGLE-DOSE (70436-127-40) 2024-04-15NoNoHistorical