FDA.reportPublic FDA data

isoproterenol hydrochloride

Product NDC
68083-586
11-digit product format
680830586
Labeler code
68083
Product ID
68083-586_a5d2e484-b959-4eef-9988-290ea1668c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoproterenol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA217648
Marketing category
ANDA
Marketing start
2024-10-03
Substance
ISOPROTERENOL HYDROCHLORIDE
Active strength
1 mg/5mL
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
isoproterenol hydrochlorideISOPROTERENOL HYDROCHLORIDEGland Pharma Limited2581854e-e654-4ac3-98e8-36c9f27748bf2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217648
application number: ANDA217648
ndc (product): 68083-586

Additional Listing Data#

Finished product
Yes
Brand name base
isoproterenol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROTERENOL HYDROCHLORIDE1 mg/5mL

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
2581854e-e654-4ac3-98e8-36c9f27748bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7757a57a-4dcc-4536-b5df-2fed4aa930c9Product name920240506
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-586-10isoproterenol hydrochloride5 mL in 1 VIALINJECTION, SOLUTION54
68083-586-10isoproterenol hydrochloride10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-586ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20241010_2581854e-e654-4ac3-98e8-36c9f27748bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSN2581854e-e654-4ac3-98e8-36c9f27748bf4
1667915isoproterenol 1 MG in 5 ML InjectionPSN2581854e-e654-4ac3-98e8-36c9f27748bf4
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD2581854e-e654-4ac3-98e8-36c9f27748bf4
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD2581854e-e654-4ac3-98e8-36c9f27748bf4
1667909isoproterenol 0.2 MG per 1 ML InjectionSY2581854e-e654-4ac3-98e8-36c9f27748bf4
1667915isoproterenol 1 MG per 5 ML InjectionSY2581854e-e654-4ac3-98e8-36c9f27748bf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-586-106808305861010 VIAL in 1 CARTON (68083-586-10) / 5 mL in 1 VIAL10 vial2024-10-03NoNoCurrent