Hydroxyzine Pamoate

Product NDC
0185-0613
11-digit product format
001850613
Labeler code
0185
Product ID
0185-0613_d42fe10f-8a8a-4c0c-a148-736e98f757db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
2019-04-10
Substance
HYDROXYZINE PAM
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0185-0613-01Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE10036
0185-0613-05Hydroxyzine Pamoate500 in 1 BOTTLECAPSULE50036
0185-0613-10Hydroxyzine Pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0613-01EA - Each0185-06136fc4dca6-123f-4683-86ca-8c1d634055f312012-07-24
0185-0613-05EA - Each0185-06135e212c8d-dfab-4a37-bd65-f222dd1c3d6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]20
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0613HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]36Legacy NDC, 3 package rows20240320_c38cfd32-2562-4d6c-8a2e-d9984c16d9eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNba04ac99-6321-4431-97e1-e18083d7b1373
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNba04ac99-6321-4431-97e1-e18083d7b1373
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYba04ac99-6321-4431-97e1-e18083d7b1373
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb6a5fb1e-b133-452d-ba97-84c1cca03fc11
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb6a5fb1e-b133-452d-ba97-84c1cca03fc11
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY2bbcabc3-657f-4b2e-a473-774adfeba78e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0185-0613-0100185061301100 in 1 BOTTLEHistorical
0185-0613-0500185061305500 in 1 BOTTLEHistorical
0185-0613-10001850613101000 in 1 BOTTLEHistorical