Hydroxyzine Pamoate

Product NDC
67296-0152
11-digit product format
672960152
Labeler code
67296
Product ID
67296-0152_291ca54c-dadb-4e47-abb3-8f937ab6ef08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug Inc.
Application
ANDA088496
Marketing category
ANDA
Marketing start
2010-07-01
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
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
67296-0152-22019-10-29C16284748780-1960f7f55-cac1-8e05-e053-dbdaa90a074aHYDROXYZINE PAMOATE Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0152-2Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0152HYDROXYZINE PAMOATE CAPSULE [REDPHARM DRUG INC.]5Legacy NDC, 1 package rows20110729_740fad03-94a7-4da6-86e2-a1622d907f27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN740fad03-94a7-4da6-86e2-a1622d907f275
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD740fad03-94a7-4da6-86e2-a1622d907f275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0152-26729601520230 in 1 BOTTLEHistorical