Hydroxyzine Pamoate

Product NDC
70518-3311
11-digit product format
705183311
Labeler code
70518
Product ID
70518-3311_ea4dc439-f085-3f0b-e053-2995a90ae4f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088487
Marketing category
ANDA
Marketing start
2021-12-27
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3311-070518331100100 POUCH in 1 BOX (70518-3311-0) > 1 CAPSULE in 1 POUCH (70518-3311-1) 100 pouch2021-12-270000-00-00NoNoCurrent
70518-3311-27051833110230 CAPSULE in 1 BLISTER PACK (70518-3311-2) 30 capsule2022-03-210000-00-00NoNoCurrent
70518-3311-37051833110330 CAPSULE in 1 BLISTER PACK (70518-3311-3) 30 capsule2022-08-250000-00-00NoNoCurrent