FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
72485-113
11-digit product format
724850113
Labeler code
72485
Product ID
72485-113_f62c3ef7-c8bd-4517-8ca9-b22829516dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA210845
Marketing category
ANDA
Marketing start
2021-08-06
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
Rxcui1667915

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72485-113-102023-08-01C16284748780-1f386c64a-1d32-0266-e053-dadaa90a7c1aRx only These highlights do not include all the information needed to use ISOPROTERENOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ISOPROTERENOL HYDROCHLORIDE INJECTION. ISOPROTERENOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1956
72485-113-102023-01-30C16284748780-1f386c64a-1d32-0266-e053-dadaa90a7c1aRx only These highlights do not include all the information needed to use ISOPROTERENOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ISOPROTERENOL HYDROCHLORIDE INJECTION. ISOPROTERENOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-113-01Isoproterenol Hydrochloride5 mL in 1 AMPULEINJECTION52
72485-113-10Isoproterenol Hydrochloride10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-113-01ML - Milliliter72485-113e8ac61fe-4ded-496c-9721-9fb68460217712021-09-07
72485-113-10ML - Milliliter72485-113c4182b2b-f835-4b8a-8cfc-4db54eb1652412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-113ISOPROTERENOL HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230802_56cb205c-8329-454a-a6be-e05e497de81e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667915isoproterenol 1 MG in 5 ML InjectionPSN56cb205c-8329-454a-a6be-e05e497de81e2
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD56cb205c-8329-454a-a6be-e05e497de81e2
1667915isoproterenol 1 MG per 5 ML InjectionSY56cb205c-8329-454a-a6be-e05e497de81e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-113-01724850113015 mL in 1 AMPULE5 mlHistorical
72485-113-107248501131010 AMPULE in 1 CARTON (72485-113-10) / 5 mL in 1 AMPULE (72485-113-01) 10 ampule2021-08-060000-00-00NoNoCurrent