Home NDC 10702-364-51 Isoproterenol hydrochloride
Product NDC 10702-364
Requested package NDC 10702-364-51
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 2026-02-19 14:30 UTC 2026-02 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215542-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION AP 2022-09-20 a50c72e98297…
Observed Orange Book normalized TE history# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10702-364-51 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