FDA.reportPublic FDA data

HYDROXYZINE PAMOATE

Product NDC
64980-169
11-digit product format
649800169
Labeler code
64980
Product ID
64980-169_6491d5b0-7f1b-4ac0-8791-308401000e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals Inc.
Application
ANDA201507
Marketing category
ANDA
Marketing start
2010-11-17
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64980-169-012025-07-23C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-169-052025-07-23C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-169-012020-01-31C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-169-052020-01-31C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-169-01EA - Each64980-169478b0198-aff8-46da-b748-de8fdc5efe1012013-11-04
64980-169-05EA - Each64980-1698ab2670d-f753-4ccf-919c-81f654efa62212013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]10
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE 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 RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-169HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]11Legacy NDC20170411_28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN873ccc16-b42f-408b-87ba-d336b09d79719
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD873ccc16-b42f-408b-87ba-d336b09d79719
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN29130fb6-7920-4cea-af10-7d23029a71404
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN29130fb6-7920-4cea-af10-7d23029a71404
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD29130fb6-7920-4cea-af10-7d23029a71404
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD29130fb6-7920-4cea-af10-7d23029a71404
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY29130fb6-7920-4cea-af10-7d23029a71404
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNcc4651a4-7460-4fa8-8d21-26e1968682f63
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN7adec0fc-385b-4e2b-b7c5-318cc17ce9a53
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD7adec0fc-385b-4e2b-b7c5-318cc17ce9a53
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDcc4651a4-7460-4fa8-8d21-26e1968682f63
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
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN480add5c-5f90-69d8-e054-00144ff88e882
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD480add5c-5f90-69d8-e054-00144ff88e882
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa50ee238-faef-a1da-e053-2a95a90af9651
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa852d881-3c34-447e-9ed8-1d547cefb75e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa50ee238-faef-a1da-e053-2a95a90af9651
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa852d881-3c34-447e-9ed8-1d547cefb75e1