Hydroxyzine Hydrochloride

Product NDC
68788-7676
11-digit product format
687887676
Labeler code
68788
Product ID
68788-7676_97f91413-b41a-4f5f-9978-429da0191e4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA088617
Marketing category
ANDA
Marketing start
2020-03-02
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7676-32023-07-12C16284748780-1d6a99b39-55e5-a426-e053-dadaa90af4c297f91413-b41a-4f5f-9978-429da0191e4e
68788-7676-32022-01-28C16284748780-1d6a99b39-55e5-a426-e053-dadaa90af4c297f91413-b41a-4f5f-9978-429da0191e4e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7676-3EA - Each68788-7676a41c6244-f784-42d9-a969-c31c0804274a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7676HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3Legacy NDC20240524_97f91413-b41a-4f5f-9978-429da0191e4e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7676-36878876760330 TABLET, FILM COATED in 1 BOTTLE (68788-7676-3) 2020-03-020000-00-00NoNoCurrent