FDA.reportPublic FDA data

isoproterenol hydrochloride

Product NDC
68083-585
11-digit product format
680830585
Labeler code
68083
Product ID
68083-585_a5d2e484-b959-4eef-9988-290ea1668c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoproterenol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA217648
Marketing category
ANDA
Marketing start
2024-10-03
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
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
68083-585-25isoproterenol hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
68083-585-25isoproterenol hydrochloride1 mL in 1 VIALINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-585ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20241010_2581854e-e654-4ac3-98e8-36c9f27748bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSN2581854e-e654-4ac3-98e8-36c9f27748bf4
1667915isoproterenol 1 MG in 5 ML InjectionPSN2581854e-e654-4ac3-98e8-36c9f27748bf4
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD2581854e-e654-4ac3-98e8-36c9f27748bf4
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD2581854e-e654-4ac3-98e8-36c9f27748bf4
1667909isoproterenol 0.2 MG per 1 ML InjectionSY2581854e-e654-4ac3-98e8-36c9f27748bf4
1667915isoproterenol 1 MG per 5 ML InjectionSY2581854e-e654-4ac3-98e8-36c9f27748bf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-585-256808305852525 VIAL in 1 CARTON (68083-585-25) / 1 mL in 1 VIAL25 vial2024-10-03NoNoHistorical