FDA.reportPublic FDA data

Icatibant

Product NDC
0093-3066
11-digit product format
000933066
Labeler code
0093
Product ID
0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Icatibant
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA210118
Marketing category
ANDA
Marketing start
2019-07-15
Substance
ICATIBANT ACETATE
Active strength
10 mg/mL
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 ACETATE10 mg/mL

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
0093-3066-19Icatibant3 mL in 1 SYRINGEINJECTION, SOLUTION39
0093-3066-19Icatibant1 in 1 CARTONINJECTION, SOLUTION19
0093-3066-34Icatibant3 mL in 1 SYRINGEINJECTION, SOLUTION39
0093-3066-34Icatibant1 in 1 CARTONINJECTION, SOLUTION19
0093-3066-93Icatibant3 in 1 BOXINJECTION, SOLUTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3066-19ML - Milliliter0093-30669e2f5fc5-e960-4299-a026-ff7a0b013a3a12019-08-06
0093-3066-34ML - Milliliter0093-30661d175624-880b-403f-915e-b1cd1a85db8b12019-08-06
0093-3066-93ML - Milliliter0093-30669b249484-631c-40e3-9911-eeb0165a6cd112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3066ICATIBANT INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.]9Current NDC, Legacy NDC, 5 package rows20250212_402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148141icatibant 30 MG in 3 ML Prefilled SyringePSN402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b39
11481413 ML icatibant 10 MG/ML Prefilled SyringeSCD402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b39
1148141icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled SyringeSY402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3066-19000933066193 mL in 1 SYRINGE3 mlHistorical
0093-3066-34000933066341 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE1 syringe2019-07-150000-00-00NoNoCurrent
0093-3066-93000933066933 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE3 carton2019-07-150000-00-00NoNoCurrent