FDA.reportPublic FDA data

Ibutilide Fumarate

Product NDC
23155-326
11-digit product format
231550326
Labeler code
23155
Product ID
23155-326_d27fccf1-d015-47a7-9fff-2d028495a1fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibutilide Fumarate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204146
Marketing category
ANDA
Marketing start
2024-04-01
Substance
IBUTILIDE FUMARATE
Active strength
1 mg/10mL
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUTILIDE FUMARATE1 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9L5X4M5L6I
Rxcui979120

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f837fb5b-10aa-c70b-4dd0-ccab4fc5a43eProduct name220250128
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-326-31Ibutilide Fumarate1 in 1 CARTONINJECTION, SOLUTION15
23155-326-31Ibutilide Fumarate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-326-31ML - Milliliter23155-326f1064933-9645-45ca-a90f-a6f1ab6713a012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-326IBUTILIDE FUMARATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, 2 package rows20240403_0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979120ibutilide fumarate 1 MG in 10 ML InjectionPSN0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd05
97912010 ML ibutilide fumarate 0.1 MG/ML InjectionSCD0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd05
979120ibutilide fumarate 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML InjectionSY0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd05
979120ibutilide fumarate 1 MG per 10 ML InjectionSY0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-326-31231550326311 VIAL, GLASS in 1 CARTON (23155-326-31) / 10 mL in 1 VIAL, GLASS2024-04-01NoNoCurrent