FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
23155-660
11-digit product format
231550660
Labeler code
23155
Product ID
23155-660_b069b673-fa32-435a-814e-667646a7adb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA212189
Marketing category
ANDA
Marketing start
2021-11-19
Substance
ISOPROTERENOL HYDROCHLORIDE
Active strength
.2 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROTERENOL HYDROCHLORIDE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDIA2A74855
Rxcui1667909, 1667915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7757a57a-4dcc-4536-b5df-2fed4aa930c9Product name920240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-660-31Isoproterenol Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION112
23155-660-41Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1012
23155-660-42Isoproterenol Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2512
23155-660-43Isoproterenol Hydrochloride5 in 1 CARTONINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-660-31ML - Milliliter23155-660f7101751-2735-4076-b1e3-862c02c5bcea12022-04-06
23155-660-43ML - Milliliter23155-660aa6a123c-68fb-48d2-92ec-1cad1c8c0cd212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-660ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 4 package rows20240103_d140b27a-3bf7-4e0f-bb91-02b588184f52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSNd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667915isoproterenol 1 MG in 5 ML InjectionPSNd140b27a-3bf7-4e0f-bb91-02b588184f5212
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd140b27a-3bf7-4e0f-bb91-02b588184f5212
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667909isoproterenol 0.2 MG per 1 ML InjectionSYd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667915isoproterenol 1 MG per 5 ML InjectionSYd140b27a-3bf7-4e0f-bb91-02b588184f5212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-660-31231550660311 mL in 1 VIAL1 mlHistorical
23155-660-412315506604110 VIAL in 1 CARTON (23155-660-41) / 1 mL in 1 VIAL (23155-660-31) 10 vial2021-11-190000-00-00NoNoCurrent
23155-660-422315506604225 VIAL in 1 CARTON (23155-660-42) / 1 mL in 1 VIAL (23155-660-31) 25 vial2021-11-190000-00-00NoNoCurrent
23155-660-43231550660435 VIAL in 1 CARTON (23155-660-43) / 1 mL in 1 VIAL (23155-660-31) 5 vial2021-11-190000-00-00NoNoCurrent