isoproterenol hydrochloride

Generic: isoproterenol hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isoproterenol hydrochloride
Generic Name isoproterenol hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

isoproterenol hydrochloride 1 mg/5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-586
Product ID 68083-586_a5d2e484-b959-4eef-9988-290ea1668c61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217648
Listing Expiration 2026-12-31
Marketing Start 2024-10-03

Pharmacologic Class

Classes
adrenergic beta-agonists [moa] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083586
Hyphenated Format 68083-586

Supplemental Identifiers

RxCUI
1667909 1667915
UNII
DIA2A74855

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isoproterenol hydrochloride (source: ndc)
Generic Name isoproterenol hydrochloride (source: ndc)
Application Number ANDA217648 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-586-10) / 5 mL in 1 VIAL
source: ndc

Packages (1)

68083-586-10 10 VIAL in 1 CARTON (68083-586-10) / 5 mL in 1 VIAL

Ingredients (1)

isoproterenol hydrochloride (1 mg/5mL)

Linked Drug Pages (1)

isoproterenol hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a5d2e484-b959-4eef-9988-290ea1668c61", "openfda": {"unii": ["DIA2A74855"], "rxcui": ["1667909", "1667915"], "spl_set_id": ["2581854e-e654-4ac3-98e8-36c9f27748bf"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-586-10)  / 5 mL in 1 VIAL", "package_ndc": "68083-586-10", "marketing_start_date": "20241003"}], "brand_name": "isoproterenol hydrochloride", "product_id": "68083-586_a5d2e484-b959-4eef-9988-290ea1668c61", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Agonists [MoA]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "68083-586", "generic_name": "isoproterenol hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "isoproterenol hydrochloride", "active_ingredients": [{"name": "ISOPROTERENOL HYDROCHLORIDE", "strength": "1 mg/5mL"}], "application_number": "ANDA217648", "marketing_category": "ANDA", "marketing_start_date": "20241003", "listing_expiration_date": "20261231"}