HYDROXYZINE HYDROCHLORIDE

Product NDC
13668-582
11-digit product format
136680582
Labeler code
13668
Product ID
13668-582_d91b8366-0757-47c3-e053-2995a90a05c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA210634
Marketing category
ANDA
Marketing start
2019-02-26
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/5mL
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
13668-582-102021-11-12C16284748780-1ba0f9c33-1b41-a910-e053-dadaa90a0b855e844eca-fa8e-4fde-a767-2da5f3303a82
13668-582-102021-01-29C16284748780-1ba0f9c33-1b41-a910-e053-dadaa90a0b855e844eca-fa8e-4fde-a767-2da5f3303a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-582-1013668058210473 mL in 1 BOTTLE (13668-582-10) 473 ml2019-02-260000-00-00NoNoCurrent