Hydroxyzine Pamoate

Product NDC
43353-199
11-digit product format
433530199
Labeler code
43353
Product ID
43353-199_f76944fe-c1e8-4cd6-a7ec-72b0a243c590
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-199-304335301993030 CAPSULE in 1 BOTTLE, PLASTIC (43353-199-30) 30 capsule2011-03-150000-00-00NoNoCurrent
43353-199-534335301995360 CAPSULE in 1 BOTTLE, PLASTIC (43353-199-53) 60 capsule2011-03-100000-00-00NoNoCurrent
43353-199-604335301996090 CAPSULE in 1 BOTTLE, PLASTIC (43353-199-60) 90 capsule2011-03-100000-00-00NoNoCurrent
43353-199-7043353019970120 CAPSULE in 1 BOTTLE, PLASTIC (43353-199-70) 120 capsule2011-07-080000-00-00NoNoCurrent
43353-199-8043353019980180 CAPSULE in 1 BOTTLE, PLASTIC (43353-199-80) 180 capsule2011-07-080000-00-00NoNoCurrent