hydroxyzine pamoate

Product NDC
70518-3452
11-digit product format
705183452
Labeler code
70518
Product ID
70518-3452_ebc8cb9c-a0c8-d272-e053-2995a90afbd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2022-07-15
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3452HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]8Legacy NDC20241006_6a359732-3e2b-4ea8-84df-60ae4024b3dc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3452-07051834520060 CAPSULE in 1 BLISTER PACK (70518-3452-0) 60 capsule2022-07-150000-00-00NoNoCurrent
70518-3452-17051834520130 CAPSULE in 1 BLISTER PACK (70518-3452-1) 30 capsule2022-08-140000-00-00NoNoCurrent
70518-3452-3705183452031 BOX in 1 POUCH (70518-3452-3) > 100 CAPSULE in 1 BOX (70518-3452-2) 1 box2022-10-190000-00-00NoNoCurrent