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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217648-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2024-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217648-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217648-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2024-10-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217648-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDESagent Pharmaceuticalsd2a9b767-0274-49bf-83cd-2fcce9bedc782025-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217648
application number: ANDA217648
ndc (product): 25021-324
isoproterenol hydrochlorideISOPROTERENOL HYDROCHLORIDEGland Pharma Limited2581854e-e654-4ac3-98e8-36c9f27748bf2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217648
application number: ANDA217648

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DIA2A74855Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1667909Internal RxNorm lookup
1667915Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2a9b767-0274-49bf-83cd-2fcce9bedc78Available on FDA.report

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