hydroxyzine pamoate

Product NDC
70518-2350
11-digit product format
705182350
Labeler code
70518
Product ID
70518-2350_e60d938c-b9a8-6a5b-e053-2995a90aba7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2019-10-08
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2350HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]12Legacy NDC20250423_f3d9749d-0dc8-47b3-8d3c-0bb6495a5a03.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2350-07051823500030 CAPSULE in 1 BLISTER PACK (70518-2350-0) 30 capsule2019-10-080000-00-00NoNoCurrent
70518-2350-270518235002100 POUCH in 1 BOX (70518-2350-2) > 1 CAPSULE in 1 POUCH (70518-2350-1) 100 pouch2022-03-090000-00-00NoNoCurrent