Hydroxyzine Pamoate

Product NDC
64725-0801
11-digit product format
647250801
Labeler code
64725
Product ID
64725-0801_2d448e1b-79d2-4342-83ec-ed95113d6611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-06-15
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 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
64725-0801-12019-11-27C16284748780-19855e2a2-37ec-60a7-e053-dbdaa90a05bdHydrOXYzine Pamoate Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0801-1Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE1004

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
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0801HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]4Legacy NDC, 1 package rows20140921_17c106d6-386a-4d27-859a-a8f96a5cdb54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN17c106d6-386a-4d27-859a-a8f96a5cdb544
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN17c106d6-386a-4d27-859a-a8f96a5cdb544
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD17c106d6-386a-4d27-859a-a8f96a5cdb544
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD17c106d6-386a-4d27-859a-a8f96a5cdb544
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY17c106d6-386a-4d27-859a-a8f96a5cdb544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0801-164725080101100 in 1 BOTTLEHistorical