REZIPRES

Product NDC
39822-1410
11-digit product format
398221410
Labeler code
39822
Product ID
39822-1410_109f0168-154e-4fc1-8ab2-cd6aeacd87f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
NDA213536
Marketing category
NDA
Marketing start
2021-06-14
Marketing end
0000-00-00
Substance
EPHEDRINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1410-5ML - Milliliter39822-1410362c69a2-45f1-493c-ba0f-0bb010711fb912022-04-06
39822-1410-6ML - Milliliter39822-1410e51fad69-5e22-458e-bf79-b6f17a4156fa12022-04-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-1410-63982214100610 AMPULE in 1 CARTON (39822-1410-6) > 5 mL in 1 AMPULE (39822-1410-5) 10 ampule2021-11-010000-00-00NoNoCurrent