FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
0555-0302
11-digit product format
005550302
Labeler code
0555
Product ID
0555-0302_c307ca43-d41f-401b-bd15-0c753eca86e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA088487
Marketing category
ANDA
Marketing start
1984-07-01
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
Rxcui995232, 995253, 995278

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
0555-0302-02Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE10020
0555-0302-04Hydroxyzine Pamoate500 in 1 BOTTLECAPSULE50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0302-02EA - Each0555-03028cc3894c-2f58-4823-b013-a288bd9aaf3012012-07-24
0555-0302-04EA - Each0555-03022f8d99d9-2d70-4535-9893-587574b56dcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]9
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0302HYDROXYZINE PAMOATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 2 package rows20221020_06068fff-2e79-4721-bcc7-b0938aa20e7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSN06068fff-2e79-4721-bcc7-b0938aa20e7a20
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN06068fff-2e79-4721-bcc7-b0938aa20e7a20
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN06068fff-2e79-4721-bcc7-b0938aa20e7a20
995232hydroxyzine pamoate 100 MG Oral CapsuleSCD06068fff-2e79-4721-bcc7-b0938aa20e7a20
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD06068fff-2e79-4721-bcc7-b0938aa20e7a20
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD06068fff-2e79-4721-bcc7-b0938aa20e7a20
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSY06068fff-2e79-4721-bcc7-b0938aa20e7a20
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY06068fff-2e79-4721-bcc7-b0938aa20e7a20
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNe1a7d95c-e6f6-4a89-90b0-002156e90b415
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDe1a7d95c-e6f6-4a89-90b0-002156e90b415
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYe1a7d95c-e6f6-4a89-90b0-002156e90b415
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN1094b1ca-bb30-435c-8b2a-27d9fc79f1194
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN1094b1ca-bb30-435c-8b2a-27d9fc79f1194
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN0fa8b4a6-76d6-440b-97b6-e67df490881f4
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD1094b1ca-bb30-435c-8b2a-27d9fc79f1194
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD1094b1ca-bb30-435c-8b2a-27d9fc79f1194
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD0fa8b4a6-76d6-440b-97b6-e67df490881f4
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY1094b1ca-bb30-435c-8b2a-27d9fc79f1194
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY0fa8b4a6-76d6-440b-97b6-e67df490881f4
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb450ec67-4217-4627-9265-0a416f6c7e283
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb450ec67-4217-4627-9265-0a416f6c7e283
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb450ec67-4217-4627-9265-0a416f6c7e283
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNfaf7932b-40ee-8822-e053-6394a90a5e402
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDfaf7932b-40ee-8822-e053-6394a90a5e402
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYfaf7932b-40ee-8822-e053-6394a90a5e402
995232hydrOXYzine pamoate 100 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydrOXYzine pamoate 100 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNddc140c6-9919-4d69-a201-50f2308e147f1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine pamoate 100 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine pamoate 100 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDddc140c6-9919-4d69-a201-50f2308e147f1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSYb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSY82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYddc140c6-9919-4d69-a201-50f2308e147f1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY82187031-779e-47bc-943c-eb1a1ef30a7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0302-0200555030202100 CAPSULE in 1 BOTTLE (0555-0302-02) 100 capsule1984-07-010000-00-00NoNoCurrent
0555-0302-0400555030204500 CAPSULE in 1 BOTTLE (0555-0302-04) 500 capsule1984-07-010000-00-00NoNoCurrent