FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
55150-317
11-digit product format
551500317
Labeler code
55150
Product ID
55150-317_a2c8dee4-69b8-479b-a203-25fdd0c234f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA211864
Marketing category
ANDA
Marketing start
2021-02-09
Substance
ISOPROTERENOL HYDROCHLORIDE
Active strength
1 mg/5mL
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 HYDROCHLORIDE1 mg/5mL

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-317-01Isoproterenol Hydrochloride5 mL in 1 AMPULEINJECTION, SOLUTION55
55150-317-10Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-317-01ML - Milliliter55150-31722e78589-2740-4956-809f-605571559d6e12021-12-08
55150-317-10ML - Milliliter55150-317537e5484-36fd-4af9-ba74-8eac24d6664612021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-317ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]4Current NDC, Legacy NDC, 2 package rows20240906_3e4050e8-7d94-4ed7-951d-1ff818ddadf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSN3e4050e8-7d94-4ed7-951d-1ff818ddadf15
1667915isoproterenol 1 MG in 5 ML InjectionPSN3e4050e8-7d94-4ed7-951d-1ff818ddadf15
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD3e4050e8-7d94-4ed7-951d-1ff818ddadf15
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD3e4050e8-7d94-4ed7-951d-1ff818ddadf15
1667909isoproterenol 0.2 MG per 1 ML InjectionSY3e4050e8-7d94-4ed7-951d-1ff818ddadf15
1667915isoproterenol 1 MG per 5 ML InjectionSY3e4050e8-7d94-4ed7-951d-1ff818ddadf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-317-01551500317015 mL in 1 AMPULE5 mlHistorical
55150-317-105515003171010 AMPULE in 1 CARTON (55150-317-10) / 5 mL in 1 AMPULE (55150-317-01) 10 ampule2021-02-090000-00-00NoNoCurrent