Home NDC 69097-521 ISOPROTERENOL
Product NDC 69097-521
11-digit product format 690970521
Labeler code 69097
Product ID 69097-521_6014b0c8-2851-4111-a4f7-6764be850176
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isoproterenol hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Cipla USA Inc.
Application ANDA210322
Marketing category ANDA
Marketing start 2018-06-26
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 2026-12-31
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 A210322-001 ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION 2018-06-12
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 A210322-001 ISOPROTERENOL HYDROCHLORIDE 0.2MG/ML INJECTABLE / INJECTION 2018-06-12 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
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1667909 Internal RxNorm lookup 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 69097-521-31 ISOPROTERENOL 25 in 1 CARTON INJECTION, SOLUTION 25 7 69097-521-31 ISOPROTERENOL 1 mL in 1 AMPULE INJECTION, SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-521 ISOPROTERENOL (ISOPROTERENOL HYDROCHLORIDE) INJECTION, SOLUTION [CIPLA USA INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240118_f724120d-da28-4065-9e05-d7dd6afbb546.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-521-31 69097052131 25 AMPULE in 1 CARTON (69097-521-31) / 1 mL in 1 AMPULE 25 ampule 2018-06-26 0000-00-00 No No Current