HYDRALAZINE HYDROCHLORIDE

Product NDC
0404-9875
11-digit product format
004049875
Labeler code
0404
Product ID
0404-9875_8fa0485c-1dad-4186-a5e9-548a96f544e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA040730
Marketing category
ANDA
Marketing start
2022-01-11
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9875-01004049875011 VIAL, SINGLE-DOSE in 1 BAG (0404-9875-01) > 1 mL in 1 VIAL, SINGLE-DOSE2022-01-110000-00-00NoNoCurrent