FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
53808-0373
11-digit product format
538080373
Labeler code
53808
Product ID
53808-0373_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA088496
Marketing category
ANDA
Marketing start
2009-07-01
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
2018-12-31
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
53808-0373-12021-01-29C16284748780-1956f9ecf-d3cb-621f-e053-dbdaa90a74adHYDROXYZINE PAMOATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0373-1Hydroxyzine Pamoate30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
53808-0373HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_b1836032-29b4-43ae-a110-14ac2f9f1d3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995232hydroxyzine pamoate 100 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDb1836032-29b4-43ae-a110-14ac2f9f1d3e1
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
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYb1836032-29b4-43ae-a110-14ac2f9f1d3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0373-15380803730130 in 1 BLISTER PACKHistorical