EPHEDRINE SULFATE

Product NDC
42023-253
11-digit product format
420230253
Labeler code
42023
Product ID
42023-253_ff906bee-e4eb-4800-b67d-8b0125beb7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Pharmaceutical, Inc.
Application
NDA213994
Marketing category
NDA
Marketing start
2022-05-31
Marketing end
0000-00-00
Substance
EPHEDRINE SULFATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-253-05EPHEDRINE SULFATE5 mL in 1 SYRINGEINJECTION511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-253EPHEDRINE SULFATE INJECTION [ENDO USA, INC.]9Legacy NDC, 1 package rows20240425_2c203482-8a04-40fc-93d2-74b30dec7742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586841ePHEDrine sulfate 25 MG in 5 ML Prefilled SyringePSN2c203482-8a04-40fc-93d2-74b30dec774211
2368456ePHEDrine sulfate 50 MG in 10 ML InjectionPSN2c203482-8a04-40fc-93d2-74b30dec774211
236845610 ML ephedrine sulfate 5 MG/ML InjectionSCD2c203482-8a04-40fc-93d2-74b30dec774211
25868415 ML ephedrine sulfate 5 MG/ML Prefilled SyringeSCD2c203482-8a04-40fc-93d2-74b30dec774211
2586841ephedrine sulfate 25 MG (equivalent to 19 MG ephedrine) per 5 ML Prefilled SyringeSY2c203482-8a04-40fc-93d2-74b30dec774211
2368456ephedrine sulfate 50 MG per 10 ML InjectionSY2c203482-8a04-40fc-93d2-74b30dec774211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-253-05420230253055 mL in 1 SYRINGE (42023-253-05) 5 ml2022-05-310000-00-00NoNoCurrent