FDA.reportPublic FDA data

ISOPROTERENOL HYDROCHLORIDE

Product NDC
0548-9501
11-digit product format
005489501
Labeler code
0548
Product ID
0548-9501_03384075-bc26-4df6-b1e3-0e20e8808d65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
ANDA210106
Marketing category
ANDA
Marketing start
2018-07-16
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
A210106-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2018-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210106-001AP

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 22:54:322026-06A210106-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2018-06-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210106-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEAmphastar Pharmaceuticals, Inc.86b2455a-0489-405e-bd0b-9f79d3c5350d2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210106
application number: ANDA210106
ndc (product): 0548-9501

Additional Listing Data#

Finished product
Yes
Brand name base
ISOPROTERENOL HYDROCHLORIDE
Listing expiration
2027-12-31

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
86b2455a-0489-405e-bd0b-9f79d3c5350dAvailable 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
0548-9501-00ISOPROTERENOL HYDROCHLORIDE1 mL in 1 VIALINJECTION, SOLUTION12
0548-9501-00ISOPROTERENOL HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-9501-00ML - Milliliter0548-95011fc61f33-7727-4c6d-b3ba-d9376db83ffc12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-9501ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20181012_86b2455a-0489-405e-bd0b-9f79d3c5350d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSN86b2455a-0489-405e-bd0b-9f79d3c5350d2
1667915isoproterenol 1 MG in 5 ML InjectionPSN86b2455a-0489-405e-bd0b-9f79d3c5350d2
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD86b2455a-0489-405e-bd0b-9f79d3c5350d2
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCD86b2455a-0489-405e-bd0b-9f79d3c5350d2
1667909isoproterenol 0.2 MG per 1 ML InjectionSY86b2455a-0489-405e-bd0b-9f79d3c5350d2
1667915isoproterenol 1 MG per 5 ML InjectionSY86b2455a-0489-405e-bd0b-9f79d3c5350d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0548-9501-000054895010010 VIAL in 1 CARTON (0548-9501-00) / 1 mL in 1 VIAL10 vial2018-07-160000-00-00NoNoCurrent