HYDRALAZINE HYDROCHLORIDE

Product NDC
52584-934
11-digit product format
525840934
Labeler code
52584
Product ID
52584-934_e64f1ded-b66a-4c2e-8fb3-44b3ef0f1385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA040730
Marketing category
ANDA
Marketing start
2018-09-07
Marketing end
2022-10-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-934-01525840934011 VIAL, SINGLE-DOSE in 1 BAG (52584-934-01) > 1 mL in 1 VIAL, SINGLE-DOSE2018-09-072022-10-31NoNoCurrent