hydroxyzine pamoate

Product NDC
0185-0615
11-digit product format
001850615
Labeler code
0185
Product ID
0185-0615_c94e4245-cac4-4d59-b3a3-64a09b67c2e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
Marketing end
2026-05-31
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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
0185-0615-01hydroxyzine pamoate100 in 1 BOTTLECAPSULE10036
0185-0615-05hydroxyzine pamoate500 in 1 BOTTLECAPSULE50036
0185-0615-10hydroxyzine pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0615-01EA - Each0185-061574b3c8f2-75f7-4c18-b380-c80aba5ccfa612012-07-24
0185-0615-05EA - Each0185-061590f2ce18-82b2-44dd-aa3e-a71b403383d212012-07-24

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 [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS 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 [AIDAREX PHARMACEUTICALS LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0615HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]36Current NDC, Legacy 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
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNba04ac99-6321-4431-97e1-e18083d7b1373
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDba04ac99-6321-4431-97e1-e18083d7b1373
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
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 CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN27800e43-e196-3eed-e054-00144ff88e881
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNf305fb4a-f78f-49ff-b679-ebe84649f5a61
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN2bbcabc3-657f-4b2e-a473-774adfeba78e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD27800e43-e196-3eed-e054-00144ff88e881
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDf305fb4a-f78f-49ff-b679-ebe84649f5a61
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY2bbcabc3-657f-4b2e-a473-774adfeba78e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY27800e43-e196-3eed-e054-00144ff88e881
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYf305fb4a-f78f-49ff-b679-ebe84649f5a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0615-0100185061501100 CAPSULE in 1 BOTTLE (0185-0615-01) 100 capsule1981-12-142026-05-31NoNoCurrent
0185-0615-0500185061505500 CAPSULE in 1 BOTTLE (0185-0615-05) 500 capsule1981-12-142026-05-31NoNoCurrent
0185-0615-10001850615101000 in 1 BOTTLEHistorical