HYDROXYZINE PAMOATE

Product NDC
43353-094
11-digit product format
433530094
Labeler code
43353
Product ID
43353-094_0fa7e671-91b0-4903-ad9a-11f538701b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA201507
Marketing category
ANDA
Marketing start
2014-05-20
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-094-30EA - Each43353-094578b6662-8317-4c38-8e06-6842705bc99712016-07-19
43353-094-53EA - Each43353-0948e2d53d3-f190-4b58-b224-64edf592fae512016-07-19
43353-094-60EA - Each43353-094999bcb42-3dba-45ee-ade3-85434b8bb77812016-07-19
43353-094-70EA - Each43353-0947c7ed64e-43af-4036-ba1b-8a4d22593be312016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-094HYDROXYZINE PAMOATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160707_84802f43-e19c-4f7e-94cd-caae945e5dd7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-094-304335300943030 CAPSULE in 1 BOTTLE (43353-094-30) 30 capsule2015-08-220000-00-00NoNoCurrent
43353-094-534335300945360 CAPSULE in 1 BOTTLE (43353-094-53) 60 capsule2015-08-070000-00-00NoNoCurrent
43353-094-604335300946090 CAPSULE in 1 BOTTLE (43353-094-60) 90 capsule2015-08-070000-00-00NoNoCurrent
43353-094-7043353009470120 CAPSULE in 1 BOTTLE (43353-094-70) 120 capsule2015-08-220000-00-00NoNoCurrent
43353-094-8043353009480180 CAPSULE in 1 BOTTLE (43353-094-80) 180 capsule2015-08-220000-00-00NoNoCurrent