FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
25021-324
11-digit product format
250210324
Labeler code
25021
Product ID
25021-324_ad9afa40-406c-408e-ad98-520674d3acfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA217648
Marketing category
ANDA
Marketing start
2025-01-15
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
25021-324-01Isoproterenol Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION11
25021-324-01Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-324-05Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-324-05Isoproterenol Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-324-01ML - Milliliter25021-324bdd6361f-df43-42c1-9e50-57d66895af0312025-03-04
25021-324-05ML - Milliliter25021-3247d6e6d5d-d631-4c2f-bd4c-f396f5ccfd2912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-324ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20250115_d2a9b767-0274-49bf-83cd-2fcce9bedc78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSNd2a9b767-0274-49bf-83cd-2fcce9bedc781
1667915isoproterenol 1 MG in 5 ML InjectionPSNd2a9b767-0274-49bf-83cd-2fcce9bedc781
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd2a9b767-0274-49bf-83cd-2fcce9bedc781
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd2a9b767-0274-49bf-83cd-2fcce9bedc781
1667909isoproterenol 0.2 MG per 1 ML InjectionSYd2a9b767-0274-49bf-83cd-2fcce9bedc781
1667915isoproterenol 1 MG per 5 ML InjectionSYd2a9b767-0274-49bf-83cd-2fcce9bedc781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-324-012502103240110 VIAL in 1 CARTON (25021-324-01) / 1 mL in 1 VIAL10 vial2025-01-15NoNoCurrent
25021-324-052502103240510 VIAL in 1 CARTON (25021-324-05) / 5 mL in 1 VIAL10 vial2025-01-15NoNoCurrent