FDA.reportPublic FDA data

Icatibant

Product NDC
62332-654
11-digit product format
623320654
Labeler code
62332
Product ID
62332-654_a4db4a1b-3bef-4498-a88f-15d09d34b8c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icatibant
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213773
Marketing category
ANDA
Marketing start
2024-06-14
Substance
ICATIBANT ACETATE
Active strength
30 mg/3mL
Pharmacologic classes
Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ICATIBANT ACETATE30 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii325O8467XK
Rxcui1148141

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94785027-dc4b-8998-43d4-c818590b3995Product name620241008
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-654-03Icatibant1 in 1 CARTONINJECTION18
62332-654-03Icatibant3 mL in 1 SYRINGE, GLASSINJECTION38
62332-654-09Icatibant3 in 1 CARTONINJECTION38
62332-654-09Icatibant3 mL in 1 SYRINGE, GLASSINJECTION38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-654-03ML - Milliliter62332-6540fbc73f1-13f3-42af-8250-98928c78430a12025-10-14
62332-654-09ML - Milliliter62332-654070c1515-8ac7-43f2-bd37-2fcb6f13a61a12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-654ICATIBANT INJECTION [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 4 package rows20240618_aeb5406c-9501-4f43-8134-5b02a7fa7451.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148141icatibant 30 MG in 3 ML Prefilled SyringePSNaeb5406c-9501-4f43-8134-5b02a7fa74518
11481413 ML icatibant 10 MG/ML Prefilled SyringeSCDaeb5406c-9501-4f43-8134-5b02a7fa74518
1148141icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled SyringeSYaeb5406c-9501-4f43-8134-5b02a7fa74518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-654-03623320654031 SYRINGE, GLASS in 1 CARTON (62332-654-03) / 3 mL in 1 SYRINGE, GLASS2024-06-14NoNoCurrent
62332-654-09623320654093 SYRINGE, GLASS in 1 CARTON (62332-654-09) / 3 mL in 1 SYRINGE, GLASS2024-06-14NoNoCurrent