Hydroxyzine pamoate

Product NDC
59762-5420
11-digit product format
597625420
Labeler code
59762
Product ID
59762-5420_48d8773d-8fd8-4d5a-9053-f149cae3aa9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA011459
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-07-15
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
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5420-1EA - Each59762-5420025a0880-ab0f-4bfd-931f-234ca64650f112020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-5420HYDROXYZINE PAMOATE CAPSULE [MYLAN PHARMACEUTICALS INC.]6Legacy NDC20250527_f24bb9df-eed8-4eae-80f3-a6e7853d36f2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-5420-159762542001100 CAPSULE in 1 BOTTLE (59762-5420-1) 100 capsule2020-07-150000-00-00NoNoCurrent