HYDROXYZINE PAMOATE

Product NDC
64725-0169
11-digit product format
647250169
Labeler code
64725
Product ID
64725-0169_290c9184-8e8a-4512-bc7e-20af6d596c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
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
E
Listing certified through
2017-12-31
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
64725-0169-12019-11-27C16284748780-19855e2a2-4005-60a7-e053-dbdaa90a05bdRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0169-1HYDROXYZINE PAMOATE15 in 1 CONTAINERCAPSULE154

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0169HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4Legacy NDC, 1 package rows20140925_29130fb6-7920-4cea-af10-7d23029a7140.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0169-16472501690115 in 1 CONTAINERHistorical