FDA.reportPublic FDA data

HYDROXYZINE PAMOATE

Product NDC
61919-357
11-digit product format
619190357
Labeler code
61919
Product ID
61919-357_94909b1f-18eb-c466-e053-2995a90a2243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA088496
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
61919-357-152023-01-30C16284748780-1f386c64a-2af6-0266-e053-dadaa90a7c1aHYDROXYZINE PAMOATE
61919-357-302023-01-30C16284748780-1f386c64a-2af6-0266-e053-dadaa90a7c1aHYDROXYZINE PAMOATE
61919-357-602023-01-30C16284748780-1f386c64a-2af6-0266-e053-dadaa90a7c1aHYDROXYZINE PAMOATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-357-15HYDROXYZINE PAMOATE15 in 1 BOTTLECAPSULE153
61919-357-30HYDROXYZINE PAMOATE30 in 1 BOTTLECAPSULE303
61919-357-60HYDROXYZINE PAMOATE60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-357-15EA - Each61919-3570cd4df92-a437-407e-bde8-a89404cd1a0812014-06-03
61919-357-30EA - Each61919-357ef0d3560-237b-45c4-84cb-d2659f89298112014-06-03
61919-357-60EA - Each61919-3572d051ce2-45c5-42d2-8eb7-59465bbed23812019-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-357HYDROXYZINE PAMOATE CAPSULE [DIRECT RX]3Legacy NDC, 3 package rows20191012_4290519c-dc08-40d6-94d0-1f663bb8d656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN4290519c-dc08-40d6-94d0-1f663bb8d6563
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD4290519c-dc08-40d6-94d0-1f663bb8d6563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-357-156191903571515 CAPSULE in 1 BOTTLE (61919-357-15) 15 capsule2015-01-010000-00-00NoNoCurrent
61919-357-306191903573030 CAPSULE in 1 BOTTLE (61919-357-30) 30 capsule2015-01-010000-00-00NoNoCurrent
61919-357-606191903576060 CAPSULE in 1 BOTTLE (61919-357-60) 60 capsule2014-01-010000-00-00NoNoCurrent