Hydroxyzine Hydrochloride

Product NDC
70518-3574
11-digit product format
705183574
Labeler code
70518
Product ID
70518-3574_ed1e6dfb-b68b-4ac6-e053-2995a90a722a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040604
Marketing category
ANDA
Marketing start
2022-11-09
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
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
70518-3574-07051835740090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3574-0) 2022-11-090000-00-00NoNoCurrent