FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
0115-1804
11-digit product format
001151804
Labeler code
0115
Product ID
0115-1804_bfba144b-f9a0-46c4-b55c-fe452bcd9f57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-06-15
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Pamoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995253, 995278

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
0115-1804-012024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only
0115-1804-022024-01-31C16284748780-11030e365-6a41-111a-e063-dadaa90a10e2Hydroxyzine Pamoate Capsules, USP (25 mg and 50 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1804-01Hydroxyzine Pamoate100 in 1 BOTTLE, PLASTICCAPSULE1009
0115-1804-02Hydroxyzine Pamoate500 in 1 BOTTLE, PLASTICCAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1804-01EA - Each0115-1804b6aed9f8-c772-468e-b214-4127e503545412018-04-19
0115-1804-02EA - Each0115-1804a2679daa-b186-4e0e-8749-290dc88050a412019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1804HYDROXYZINE PAMOATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, Legacy NDC, 2 package rows20240201_bc82aaaf-30c7-4afe-a908-d138ea1268ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN4ea3336a-2cc8-4e43-bc55-455fca67976e103
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD4ea3336a-2cc8-4e43-bc55-455fca67976e103
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY4ea3336a-2cc8-4e43-bc55-455fca67976e103
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbc82aaaf-30c7-4afe-a908-d138ea1268ef9
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNd60603e7-15c5-7b01-e053-2995a90ad2523
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDd60603e7-15c5-7b01-e053-2995a90ad2523
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYd60603e7-15c5-7b01-e053-2995a90ad2523
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD207d3478-ac7f-485c-b8ca-e9fcebbdcd891
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY207d3478-ac7f-485c-b8ca-e9fcebbdcd891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1804-0100115180401100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-01) 100 capsule1996-06-150000-00-00NoNoCurrent
0115-1804-0200115180402500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1804-02) 500 capsule1996-06-150000-00-00NoNoCurrent