Hydralazine Hydrochloride

Product NDC
67457-291
11-digit product format
674570291
Labeler code
67457
Product ID
67457-291_caad3abe-6681-413d-a442-93f682120a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA204680
Marketing category
ANDA
Marketing start
2016-04-29
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-291-016745702910125 VIAL, SINGLE-DOSE in 1 CARTON (67457-291-01) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-291-00) 2016-04-290000-00-00NoNoCurrent