ISOPROTERENOL

Product NDC
69097-521
11-digit product format
690970521
Labeler code
69097
Product ID
69097-521_6014b0c8-2851-4111-a4f7-6764be850176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoproterenol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA210322
Marketing category
ANDA
Marketing start
2018-06-26
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
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
69097-521-31ISOPROTERENOL25 in 1 CARTONINJECTION, SOLUTION257
69097-521-31ISOPROTERENOL1 mL in 1 AMPULEINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-521-31ML - Milliliter69097-521dfc8a347-c0dd-4dc2-9079-67244c5a798812018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-521ISOPROTERENOL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [CIPLA USA INC.]7Current NDC, Legacy NDC, 2 package rows20240118_f724120d-da28-4065-9e05-d7dd6afbb546.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSNf724120d-da28-4065-9e05-d7dd6afbb5467
1667915isoproterenol 1 MG in 5 ML InjectionPSNf724120d-da28-4065-9e05-d7dd6afbb5467
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDf724120d-da28-4065-9e05-d7dd6afbb5467
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDf724120d-da28-4065-9e05-d7dd6afbb5467
1667909isoproterenol 0.2 MG per 1 ML InjectionSYf724120d-da28-4065-9e05-d7dd6afbb5467
1667915isoproterenol 1 MG per 5 ML InjectionSYf724120d-da28-4065-9e05-d7dd6afbb5467

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-521-316909705213125 AMPULE in 1 CARTON (69097-521-31) / 1 mL in 1 AMPULE25 ampule2018-06-260000-00-00NoNoCurrent