hydroxyzine pamoate

Product NDC
70518-1504
11-digit product format
705181504
Labeler code
70518
Product ID
70518-1504_4911a104-b4e6-dabd-e063-6394a90a641a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA087479
Marketing category
ANDA
Marketing start
2018-10-08
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1504-0hydroxyzine pamoate30 in 1 BLISTER PACKCAPSULE3018
70518-1504-1hydroxyzine pamoate60 in 1 BLISTER PACKCAPSULE6018
70518-1504-2hydroxyzine pamoate30 in 1 BOTTLE, PLASTICCAPSULE3018
70518-1504-3hydroxyzine pamoate100 in 1 BOXCAPSULE10018
70518-1504-4hydroxyzine pamoate1 in 1 POUCHCAPSULE118
70518-1504-5hydroxyzine pamoate100 in 1 BOXCAPSULE10018
70518-1504-6hydroxyzine pamoate1 in 1 POUCHCAPSULE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1504HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 7 package rows20250224_6432d1aa-1e73-469e-835b-43d518963f71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN6432d1aa-1e73-469e-835b-43d518963f7118
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD6432d1aa-1e73-469e-835b-43d518963f7118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1504-07051815040030 CAPSULE in 1 BLISTER PACK (70518-1504-0) 30 capsule2018-10-080000-00-00NoNoCurrent
70518-1504-17051815040160 CAPSULE in 1 BLISTER PACK (70518-1504-1) 60 capsule2019-09-170000-00-00NoNoCurrent
70518-1504-27051815040230 CAPSULE in 1 BOTTLE, PLASTIC (70518-1504-2) 30 capsule2019-09-270000-00-00NoNoCurrent
70518-1504-370518150403100 POUCH in 1 BOX (70518-1504-3) / 1 CAPSULE in 1 POUCH (70518-1504-4) 100 pouch2021-08-040000-00-00NoNoCurrent
70518-1504-4705181504041 in 1 POUCHHistorical
70518-1504-570518150405100 in 1 BOXHistorical
70518-1504-6705181504061 in 1 POUCHHistorical