FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
70121-1605
11-digit product format
701211605
Labeler code
70121
Product ID
70121-1605_8c64f438-7d75-430c-8176-2653f7cc8d0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210576
Marketing category
ANDA
Marketing start
2018-10-22
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
A210576-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210576-001AP

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 22:54:322026-06A210576-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTIONAP2018-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210576-001AP1a50c72e98297…

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 HYDROCHLORIDEAmneal Pharmaceuticals LLCf80ce132-1570-43bf-b4a6-0ffbdea5d2182023-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210576
application number: ANDA210576
ndc (product): 70121-1605

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
f80ce132-1570-43bf-b4a6-0ffbdea5d218Available 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
70121-1605-1Isoproterenol Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION56
70121-1605-7Isoproterenol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1605-1ML - Milliliter70121-160544cfe4c8-606f-4eb7-9dd4-b3c9c41d6b9412018-11-06
70121-1605-7ML - Milliliter70121-1605195ca6d8-42aa-473b-a623-f130430d8eeb12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1605ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20230307_f80ce132-1570-43bf-b4a6-0ffbdea5d218.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667909isoproterenol 0.2 MG in 1 ML InjectionPSNf80ce132-1570-43bf-b4a6-0ffbdea5d2186
1667915isoproterenol 1 MG in 5 ML InjectionPSNf80ce132-1570-43bf-b4a6-0ffbdea5d2186
16679091 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDf80ce132-1570-43bf-b4a6-0ffbdea5d2186
16679155 ML isoproterenol hydrochloride 0.2 MG/ML InjectionSCDf80ce132-1570-43bf-b4a6-0ffbdea5d2186
1667909isoproterenol 0.2 MG per 1 ML InjectionSYf80ce132-1570-43bf-b4a6-0ffbdea5d2186
1667915isoproterenol 1 MG per 5 ML InjectionSYf80ce132-1570-43bf-b4a6-0ffbdea5d2186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1605-1701211605015 mL in 1 VIAL5 mlHistorical
70121-1605-77012116050710 VIAL in 1 CARTON (70121-1605-7) / 5 mL in 1 VIAL (70121-1605-1) 10 vial2018-10-220000-00-00NoNoCurrent