FDA.reportPublic FDA data

HYDROXYZINE PAMOATE

Product NDC
68788-7214
11-digit product format
687887214
Labeler code
68788
Product ID
68788-7214_bbd7155f-8576-4db6-8f06-7d2486cd98b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2018-07-19
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 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
68788-7214-1EA - Each68788-721457e8e299-698d-496d-9609-91c828cb438912018-09-05
68788-7214-3EA - Each68788-7214ec9115f2-1910-4a00-9a68-21b46806515612018-09-05
68788-7214-5EA - Each68788-72145b2ab5d3-90b2-4745-92e3-4c4e4719b5ab12018-09-05
68788-7214-6EA - Each68788-721411e14aca-99c9-44b8-b3a2-d9e379d2349012018-09-05
68788-7214-9EA - Each68788-721402cba237-e5c9-415a-a77d-a41f0ef8a6e312018-09-05