FDA.reportPublic FDA data

Isoproterenol Hydrochloride

Product NDC
68682-433
Requested package NDC
68682-433-01
11-digit product format
686820433
Labeler code
68682
Product ID
68682-433_0f570cea-dbf2-41e0-9789-5bf948c2eb7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoproterenol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Oceanside Pharmaceuticals
Application
NDA010515
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-11-20
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68682-43368682-433-01DDiscontinued 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HYDROCHLORIDE0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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
68682-433-01ML - Milliliter68682-433edbdf283-0e58-44d1-abfc-9fb4dd4da42112021-01-08
68682-433-05ML - Milliliter68682-4338ac2f9c9-9774-4cba-b981-caf492972e5012021-01-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-433-016868204330110 AMPULE in 1 CARTON (68682-433-01) > 1 mL in 1 AMPULE10 ampule2020-11-200000-00-00NoNoCurrent