Hydralazine Hydrochloride

Product NDC
39822-0500
11-digit product format
398220500
Labeler code
39822
Product ID
39822-0500_eedc429c-f1bd-6111-e053-2995a90a70b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA203110
Marketing category
ANDA
Marketing start
2015-06-29
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0500-1ML - Milliliter39822-050025cc7dbb-4514-4e72-911f-6b4682cc288f12015-10-02
39822-0500-4ML - Milliliter39822-0500dbb05e7e-4991-4fa8-823d-bced2744310812015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0500-43982205000425 VIAL in 1 CARTON (39822-0500-4) > 1 mL in 1 VIAL (39822-0500-1) 25 vial2015-06-290000-00-00NoNoCurrent