FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
76420-921
11-digit product format
764200921
Labeler code
76420
Product ID
76420-921_2e63fa75-efcf-d9ee-e063-6394a90ab2d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA088487
Marketing category
ANDA
Marketing start
1984-07-01
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
Rxcui995232, 995253, 995278

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-921-01Hydroxyzine Pamoate100 in 1 BOTTLECAPSULE1001
76420-921-05Hydroxyzine Pamoate500 in 1 BOTTLECAPSULE5001
76420-921-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE301
76420-921-60Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE601
76420-921-90Hydroxyzine Pamoate90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-921-01EA - Each76420-921fb248dce-dec4-4cc3-aa9f-027b5bc1029612025-03-04
76420-921-05EA - Each76420-9210345429f-bc22-4e5a-acb9-5dea9256ed6012025-03-04
76420-921-30EA - Each76420-9214104a325-d72b-49cc-befd-c32daf8f156a12025-03-04
76420-921-60EA - Each76420-921f45c9299-80f5-41ed-abbf-b7b8c7ae478512025-03-04
76420-921-90EA - Each76420-921c991c73a-d169-422d-9122-f35fc753c72b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-921HYDROXYZINE PAMOATE CAPSULE [ASCLEMED USA, INC.]1Current NDC, 5 package rows20250223_82187031-779e-47bc-943c-eb1a1ef30a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN82187031-779e-47bc-943c-eb1a1ef30a7a1
995232hydroxyzine pamoate 100 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD82187031-779e-47bc-943c-eb1a1ef30a7a1
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSY82187031-779e-47bc-943c-eb1a1ef30a7a1
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY82187031-779e-47bc-943c-eb1a1ef30a7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-921-0176420092101100 CAPSULE in 1 BOTTLE (76420-921-01) 100 capsule2025-02-18NoNoHistorical
76420-921-0576420092105500 CAPSULE in 1 BOTTLE (76420-921-05) 500 capsule2025-02-18NoNoHistorical
76420-921-307642009213030 CAPSULE in 1 BOTTLE (76420-921-30) 30 capsule2025-02-18NoNoHistorical
76420-921-607642009216060 CAPSULE in 1 BOTTLE (76420-921-60) 60 capsule2025-02-18NoNoHistorical
76420-921-907642009219090 CAPSULE in 1 BOTTLE (76420-921-90) 90 capsule2025-02-18NoNoHistorical