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

Additional Listing Data#

Finished product
Yes
Brand name base
Cardamyst
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETRIPAMIL70 mg/.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS82A18Y42P
Rxcui2730307, 2730313

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83468-070-01Cardamyst0.2 mL in 1 VIAL, SINGLE-DOSESPRAY0.21
83468-070-02Cardamyst2 in 1 CONTAINERSPRAY21
83468-070-03Cardamyst2 in 1 CARTONSPRAY21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83468-070-03EA - Each83468-07018f1cb5d-67ce-482f-be12-2961c604edf612026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2730313cardamyst 35 MG/ACTUAT Nasal SprayPSNa92170b9-4f93-4b83-b2cd-cb85c52821cd1
2730307etripamil 35 MG/ACTUAT Nasal SprayPSNa92170b9-4f93-4b83-b2cd-cb85c52821cd1
2730313etripamil 35 MG/ACTUAT Nasal Spray [Cardamyst]SBDa92170b9-4f93-4b83-b2cd-cb85c52821cd1
2730307etripamil 35 MG/ACTUAT Nasal SpraySCDa92170b9-4f93-4b83-b2cd-cb85c52821cd1
2730313Cardamyst 35 MG/ACTUAT Nasal SpraySYa92170b9-4f93-4b83-b2cd-cb85c52821cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83468-070-01834680070010.2 mL in 1 VIAL, SINGLE-DOSE0.2 mlHistorical
83468-070-02834680070022 in 1 CONTAINERHistorical
83468-070-03834680070032 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 container2026-01-05NoNoHistorical