Isoproterenol Hydrochloride

Product NDC
23155-660
11-digit product format
231550660
Labeler code
23155
Product ID
23155-660_b069b673-fa32-435a-814e-667646a7adb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA212189
Marketing category
ANDA
Marketing start
2021-11-19
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
A212189-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2021-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212189-001AP

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 22:54:322026-06A212189-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2021-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212189-001AP1a50c72e98297…

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 HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.d140b27a-3bf7-4e0f-bb91-02b588184f522025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212189
application number: ANDA212189
ndc (product): 23155-660
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEAvenacy, Inc.212af0f4-42c7-425d-8baf-9a2f594289a22024-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212189
application number: ANDA212189

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
d140b27a-3bf7-4e0f-bb91-02b588184f52Available 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
23155-660-31Isoproterenol Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION112
23155-660-41Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1012
23155-660-42Isoproterenol Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2512
23155-660-43Isoproterenol Hydrochloride5 in 1 CARTONINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-660-31ML - Milliliter23155-660f7101751-2735-4076-b1e3-862c02c5bcea12022-04-06
23155-660-43ML - Milliliter23155-660aa6a123c-68fb-48d2-92ec-1cad1c8c0cd212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-660ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 4 package rows20240103_d140b27a-3bf7-4e0f-bb91-02b588184f52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSNd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667915isoproterenol 1 MG in 5 ML InjectionPSNd140b27a-3bf7-4e0f-bb91-02b588184f5212
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd140b27a-3bf7-4e0f-bb91-02b588184f5212
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667909isoproterenol 0.2 MG per 1 ML InjectionSYd140b27a-3bf7-4e0f-bb91-02b588184f5212
1667915isoproterenol 1 MG per 5 ML InjectionSYd140b27a-3bf7-4e0f-bb91-02b588184f5212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-660-31231550660311 mL in 1 VIAL1 mlHistorical
23155-660-412315506604110 VIAL in 1 CARTON (23155-660-41) / 1 mL in 1 VIAL (23155-660-31) 10 vial2021-11-190000-00-00NoNoCurrent
23155-660-422315506604225 VIAL in 1 CARTON (23155-660-42) / 1 mL in 1 VIAL (23155-660-31) 25 vial2021-11-190000-00-00NoNoCurrent
23155-660-43231550660435 VIAL in 1 CARTON (23155-660-43) / 1 mL in 1 VIAL (23155-660-31) 5 vial2021-11-190000-00-00NoNoCurrent