hydroxyzine pamoate

Product NDC
0615-8357
11-digit product format
006158357
Labeler code
0615
Product ID
0615-8357_faa47246-9045-4195-b5c0-02bcd1e2b205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA201507
Marketing category
ANDA
Marketing start
2019-04-23
Marketing end
2023-04-30
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8357-390061583573930 CAPSULE in 1 BLISTER PACK (0615-8357-39) 30 capsule2020-11-130000-00-00NoNoCurrent