Corvert

Product NDC
0009-3794
11-digit product format
000093794
Labeler code
0009
Product ID
0009-3794_1cc20301-7541-43e5-8034-8306028c50a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibutilide fumarate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA020491
Marketing category
NDA
Marketing start
1995-12-28
Substance
IBUTILIDE FUMARATE
Active strength
.1 mg/mL
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
Corvert
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUTILIDE FUMARATE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9L5X4M5L6I
Rxcui979120, 979122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f837fb5b-10aa-c70b-4dd0-ccab4fc5a43eProduct name220250128
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-3794-01Corvert1 in 1 CARTONINJECTION, SOLUTION111
0009-3794-01Corvert10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1011
0009-3794-22Corvert1 in 1 CARTONINJECTION, SOLUTION19
0009-3794-22Corvert10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3794-01ML - Milliliter0009-3794aee5fa96-99ee-4e26-b36f-49a386d3a10712012-07-24
0009-3794-22ML - Milliliter0009-379426ffd2cd-5846-459e-b4fb-6ffd8d1e9e9812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUTILIDE FUMARATEACTIVE INGREDIENT9L5X4M5L6ICORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
IBUTILIDEACTIVE MOIETY2436VX1U9BCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]4
ibutilide fumarateACTIVE INGREDIENT9L5X4M5L6ICORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2
ibutilideACTIVE MOIETY2436VX1U9BCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2
sodium acetateINACTIVE INGREDIENT4550K0SC9BCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2
WaterINACTIVE INGREDIENT059QF0KO0RCORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-3794CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]11Current NDC, Legacy NDC, 2 package rows20240126_b7d717ed-022d-4459-b5e6-098c2a8b7427.zip
0009-3794CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]9Current NDC, Legacy NDC, 2 package rows20240126_2428969a-7431-4e94-9503-ad5c680e2ea4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979122Corvert 1 MG in 10 ML InjectionPSNb7d717ed-022d-4459-b5e6-098c2a8b742711
979120ibutilide fumarate 1 MG in 10 ML InjectionPSNb7d717ed-022d-4459-b5e6-098c2a8b742711
97912210 ML ibutilide fumarate 0.1 MG/ML Injection [Corvert]SBDb7d717ed-022d-4459-b5e6-098c2a8b742711
97912010 ML ibutilide fumarate 0.1 MG/ML InjectionSCDb7d717ed-022d-4459-b5e6-098c2a8b742711
97912210 ML Corvert 0.1 MG/ML InjectionSYb7d717ed-022d-4459-b5e6-098c2a8b742711
979122Corvert 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML InjectionSYb7d717ed-022d-4459-b5e6-098c2a8b742711
979122Corvert 1 MG per 10 ML InjectionSYb7d717ed-022d-4459-b5e6-098c2a8b742711
979120ibutilide fumarate 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML InjectionSYb7d717ed-022d-4459-b5e6-098c2a8b742711
979120ibutilide fumarate 1 MG per 10 ML InjectionSYb7d717ed-022d-4459-b5e6-098c2a8b742711
979122Corvert 1 MG in 10 ML InjectionPSN2428969a-7431-4e94-9503-ad5c680e2ea49
979120ibutilide fumarate 1 MG in 10 ML InjectionPSN2428969a-7431-4e94-9503-ad5c680e2ea49
97912210 ML ibutilide fumarate 0.1 MG/ML Injection [Corvert]SBD2428969a-7431-4e94-9503-ad5c680e2ea49
97912010 ML ibutilide fumarate 0.1 MG/ML InjectionSCD2428969a-7431-4e94-9503-ad5c680e2ea49
97912210 ML Corvert 0.1 MG/ML InjectionSY2428969a-7431-4e94-9503-ad5c680e2ea49
979122Corvert 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML InjectionSY2428969a-7431-4e94-9503-ad5c680e2ea49
979122Corvert 1 MG per 10 ML InjectionSY2428969a-7431-4e94-9503-ad5c680e2ea49
979120ibutilide fumarate 1 MG (equivalent to ibutilide 0.087 MG) per 10 ML InjectionSY2428969a-7431-4e94-9503-ad5c680e2ea49
979120ibutilide fumarate 1 MG per 10 ML InjectionSY2428969a-7431-4e94-9503-ad5c680e2ea49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-3794-01000093794011 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-01) / 10 mL in 1 VIAL, SINGLE-DOSE1995-12-280000-00-00NoNoCurrent
0009-3794-22000093794221 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-22) / 10 mL in 1 VIAL, SINGLE-DOSE1995-12-280000-00-00NoNoCurrent