FDA.reportPublic FDA data

HYDROXYZINE PAMOATE

Product NDC
64980-170
11-digit product format
649800170
Labeler code
64980
Product ID
64980-170_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
50 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
64980-170-012025-07-23C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-170-052025-07-23C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-170-012020-01-31C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38
64980-170-052020-01-31C16284748780-19d75b9d1-0690-f424-e053-dadaa90a57ce28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-170-01EA - Each64980-1704095c82e-2497-4d25-8296-054e1ef5ef4e12013-11-04
64980-170-05EA - Each64980-1700dcde2cd-2752-4290-ba62-29e8d48efdf612013-11-04

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 [WESTWOOD MANUFACTURING]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-170HYDROXYZINE 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 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
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNa5008eba-91a4-cb2f-e053-2a95a90a869e2
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNe97b2b86-bea0-4203-97c8-b27510a524a32
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDa5008eba-91a4-cb2f-e053-2a95a90a869e2
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDe97b2b86-bea0-4203-97c8-b27510a524a32
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYa5008eba-91a4-cb2f-e053-2a95a90a869e2
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYe97b2b86-bea0-4203-97c8-b27510a524a32