Home NDC 83468-070 Cardamyst
Product NDC 83468-070
11-digit product format 834680070
Labeler code 83468
Product ID 83468-070_6a4934f2-7bae-4f50-9ccc-619d7efe31e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etripamil
Dosage form SPRAY
Route NASAL
Labeler Milestone Pharmaceuticals USA, Inc.
Application NDA218571
Marketing category NDA
Marketing start 2026-01-05
Substance ETRIPAMIL
Active strength 70 mg/.2mL
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 N218571-001 CARDAMYST ETRIPAMIL 70MG SPRAY / NASAL RLD, RS 2025-12-12
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218571-001 10010522 2028-06-19 U-38 2026-01-06 N218571-001 10010523 2028-06-19 Drug substance 2026-01-06 N218571-001 9227918 2028-06-19 Drug product 2026-01-06 N218571-001 9463179 2028-06-19 U-4370 2026-01-06 N218571-001 10117848 2036-04-13 U-4370 Drug product 2026-01-06 N218571-001 12257224 2042-07-15 U-4370 2026-01-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218571-001 NCE 2030-12-12
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 2026-02-19 14:30 UTC 2026-02 N218571-001 CARDAMYST 70MG SPRAY / NASAL RLD, RS 2025-12-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 CARDAMYST 70MG SPRAY / NASAL RLD, RS 2025-12-12 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218571-001 10010522 2028-06-19 U-38 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218571-001 10010523 2028-06-19 Drug substance 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218571-001 9227918 2028-06-19 Drug product 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218571-001 9463179 2028-06-19 U-4370 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218571-001 10117848 2036-04-13 U-4370 Drug product 2026-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218571-001 12257224 2042-07-15 U-4370 2026-01-06 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 10010522 2028-06-19 U-38 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 10010523 2028-06-19 Drug substance 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 9227918 2028-06-19 Drug product 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 9463179 2028-06-19 U-4370 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 10117848 2036-04-13 U-4370 Drug product 2026-01-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 12257224 2042-07-15 U-4370 2026-01-06 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218571-001 NCE 2030-12-12 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218571-001 NCE 2030-12-12 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Cardamyst
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETRIPAMIL 70 mg/.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S82A18Y42P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2730307 Internal RxNorm lookup 2730313 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 83468-070-01 Cardamyst 0.2 mL in 1 VIAL, SINGLE-DOSE SPRAY 0.2 1 83468-070-02 Cardamyst 2 in 1 CONTAINER SPRAY 2 1 83468-070-03 Cardamyst 2 in 1 CARTON SPRAY 2 1
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 83468-070-01 83468007001 0.2 mL in 1 VIAL, SINGLE-DOSE 0.2 ml Historical 83468-070-02 83468007002 2 in 1 CONTAINER Historical 83468-070-03 83468007003 2 CONTAINER in 1 CARTON (83468-070-03) / 2 VIAL, SINGLE-DOSE in 1 CONTAINER (83468-070-02) / .2 mL in 1 VIAL, SINGLE-DOSE (83468-070-01) 2 container 2026-01-05 No No Current