Hydroxyzine Pamoate

Product NDC
52959-433
11-digit product format
529590433
Labeler code
52959
Product ID
52959-433_f261ce7f-663b-4ca6-9ee3-215ec8eeb9c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
2010-07-01
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-433-10Hydroxyzine Pamoate10 in 1 BOTTLECAPSULE103
52959-433-15Hydroxyzine Pamoate15 in 1 BOTTLECAPSULE153
52959-433-20Hydroxyzine Pamoate20 in 1 BOTTLECAPSULE203
52959-433-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE303
52959-433-40Hydroxyzine Pamoate40 in 1 BOTTLECAPSULE403
52959-433-50Hydroxyzine Pamoate50 in 1 BOTTLECAPSULE503
52959-433-60Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-433-10EA - Each52959-433a71e5aec-10fb-4032-a8f5-02aea43d8fb712012-07-24
52959-433-15EA - Each52959-433b4af22eb-3db1-4df7-909d-2f7a7cd2adae12012-07-24
52959-433-20EA - Each52959-43345e4570c-2ef8-4fa3-91d9-6b7f6a086ab012012-07-24
52959-433-30EA - Each52959-4334c498578-b4dc-4a19-b859-a8aa0a12b70a12012-07-24
52959-433-40EA - Each52959-4333cb54fda-c96f-44fa-b9d2-2591a20ee8f712012-07-24
52959-433-50EA - Each52959-43383a7ec76-0349-4964-87fb-2789fa0f2a1512012-07-24
52959-433-60EA - Each52959-4331780bbb6-b4b6-4a5c-bd4f-4e73c9583f5a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-433HYDROXYZINE PAMOATE CAPSULE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 7 package rows20120423_b0919f40-ed4f-47ce-98bc-9898b4a84862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb0919f40-ed4f-47ce-98bc-9898b4a848623
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb0919f40-ed4f-47ce-98bc-9898b4a848623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-433-105295904331010 in 1 BOTTLEHistorical
52959-433-155295904331515 in 1 BOTTLEHistorical
52959-433-205295904332020 in 1 BOTTLEHistorical
52959-433-305295904333030 in 1 BOTTLEHistorical
52959-433-405295904334040 in 1 BOTTLEHistorical
52959-433-505295904335050 in 1 BOTTLEHistorical
52959-433-605295904336060 in 1 BOTTLEHistorical