FDA.reportPublic FDA data

Isuprel

Product NDC
0187-4330
11-digit product format
001874330
Labeler code
0187
Product ID
0187-4330_86509e16-0c0a-4de2-9b19-d484b6dc2825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Bausch Health US LLC
Application
NDA010515
Marketing category
NDA
Marketing start
2013-12-01
Marketing end
0000-00-00
Substance
ISOPROTERENOL HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0187-4330DDiscontinued by firm2026-07-31
excluded packagepackage0187-43300187-4330-01DDiscontinued by firm2026-07-31
excluded packagepackage0187-43300187-4330-05DDiscontinued by firm2026-07-31

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
N010515-001ISUPRELISOPROTERENOL HYDROCHLORIDE0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 22:54:322026-06N010515-001ISUPREL0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-4330-01ML - Milliliter0187-43303cf73360-1aba-4764-a068-cac716d5d7d512015-09-10
0187-4330-05ML - Milliliter0187-433072b2fc2d-6265-448c-955c-bc1ef1bef71612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROTERENOL HYDROCHLORIDEACTIVE INGREDIENTDIA2A74855ISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ISOPROTERENOLACTIVE MOIETYL628TT009WISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RISUPREL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-4330-010018743300125 AMPULE in 1 CARTON (0187-4330-01) > 1 mL in 1 AMPULE25 ampule2013-12-010000-00-00NoNoCurrent
0187-4330-050018743300510 AMPULE in 1 CARTON (0187-4330-05) > 5 mL in 1 AMPULE10 ampule2013-12-010000-00-00NoNoCurrent