FDA.reportPublic FDA data

Hydroxyzine pamoate

Product NDC
0185-0676
11-digit product format
001850676
Labeler code
0185
Product ID
0185-0676_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
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253, 995278

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
0185-0676-01Hydroxyzine pamoate100 in 1 BOTTLECAPSULE10036
0185-0676-05Hydroxyzine pamoate500 in 1 BOTTLECAPSULE50036
0185-0676-10Hydroxyzine pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0676-01EA - Each0185-067633f39b84-b055-44b5-b1ea-f7728982894512021-10-08
0185-0676-05EA - Each0185-0676b0c98f8a-3f44-4a6e-a145-e46e2ff479cb12021-10-08

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0676HYDROXYZINE 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
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102
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
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN0c9101ee-0746-4833-83cf-d0d09e52c0a910
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD0c9101ee-0746-4833-83cf-d0d09e52c0a910
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY0c9101ee-0746-4833-83cf-d0d09e52c0a910
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN1030e6b6-7688-4756-b54b-9258016569774
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD1030e6b6-7688-4756-b54b-9258016569774
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYfcec985f-9ded-6534-e053-6294a90ac76b4
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY1030e6b6-7688-4756-b54b-9258016569774
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN737d39fd-4b11-4e8d-a546-ba9189fdbd9e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN509e9a9c-23a3-ade4-e063-6294a90a74031
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN1136a291-2f2f-c025-e063-6294a90a76d71
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD737d39fd-4b11-4e8d-a546-ba9189fdbd9e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD509e9a9c-23a3-ade4-e063-6294a90a74031
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD1136a291-2f2f-c025-e063-6294a90a76d71
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY737d39fd-4b11-4e8d-a546-ba9189fdbd9e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY509e9a9c-23a3-ade4-e063-6294a90a74031
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY1136a291-2f2f-c025-e063-6294a90a76d71
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYdd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0676-0100185067601100 CAPSULE in 1 BOTTLE (0185-0676-01) 100 capsule2021-09-140000-00-00NoNoCurrent
0185-0676-0500185067605500 CAPSULE in 1 BOTTLE (0185-0676-05) 500 capsule2021-09-140000-00-00NoNoCurrent
0185-0676-10001850676101000 in 1 BOTTLEHistorical