Hydroxyzine Hydrochloride

Product NDC
68071-2229
11-digit product format
680712229
Labeler code
68071
Product ID
68071-2229_d7701c5f-e4b4-c444-e053-2995a90a4182
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2229-62022-06-08C16284748780-1d6a99b39-7887-a426-e053-dadaa90af4c2abc187f1-8648-23e9-e053-2a95a90a64a7
68071-2229-62022-01-28C16284748780-1d6a99b39-7887-a426-e053-dadaa90af4c2abc187f1-8648-23e9-e053-2a95a90a64a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2229-6680712229066 TABLET, FILM COATED in 1 BOTTLE (68071-2229-6) 2020-07-310000-00-00NoNoCurrent