Hydroxyzine Hydrochloride

Product NDC
70934-891
11-digit product format
709340891
Labeler code
70934
Product ID
70934-891_cbf8a5a0-d4a3-6f59-e053-2995a90ac292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA088617
Marketing category
ANDA
Marketing start
2021-09-14
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 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
70934-891-157093408911515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-891-15) 2021-09-140000-00-00NoNoCurrent
70934-891-307093408913030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-891-30) 2021-09-140000-00-00NoNoCurrent