Home NDC 10702-364 Isoproterenol hydrochloride
Product NDC 10702-364
11-digit product format 107020364
Labeler code 10702
Product ID 10702-364_4d3aa6d9-0373-effd-e063-6294a90acfa5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoproterenol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler KVK-Tech, Inc.
Application ANDA215542
Marketing category ANDA
Marketing start 2023-09-25
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 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215542-001 ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215542-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A215542-001 AP 1 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Isoproterenol hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROTERENOL HYDROCHLORIDE .2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DIA2A74855 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1667915 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-364-05 Isoproterenol hydrochloride 5 mL in 1 VIAL INJECTION, SOLUTION 5 3 10702-364-51 Isoproterenol hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-364 ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [KVK-TECH, INC.] 1 Current NDC, 2 package rows 20230925_051acbc2-7bf8-4059-e063-6394a90a115b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10702-364-05 10702036405 5 mL in 1 VIAL 5 ml Historical 10702-364-51 10702036451 10 VIAL in 1 CARTON (10702-364-51) / 5 mL in 1 VIAL (10702-364-05) 10 vial 2023-09-25 No No Current