FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
0185-0674
11-digit product format
001850674
Labeler code
0185
Product ID
0185-0674_c94e4245-cac4-4d59-b3a3-64a09b67c2e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
Substance
HYDROXYZINE PAMOATE
Active strength
25 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 PAMOATE25 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0185-0674-01hydroxyzine pamoate100 in 1 BOTTLECAPSULE10036
0185-0674-05hydroxyzine pamoate500 in 1 BOTTLECAPSULE50036
0185-0674-10hydroxyzine pamoate1000 in 1 BOTTLECAPSULE100036

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0674HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]36Current NDC, Legacy NDC, 3 package rows20240320_c38cfd32-2562-4d6c-8a2e-d9984c16d9eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf74e4b3e-992c-402d-92b8-258fccb42b64106
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf74e4b3e-992c-402d-92b8-258fccb42b64106
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN02616eee-a1a4-4afc-b84e-69fd28755138105
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD02616eee-a1a4-4afc-b84e-69fd28755138105
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNfac2df9d-d395-4b07-b299-2ed946441b22102
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDfac2df9d-d395-4b07-b299-2ed946441b22102
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2a869704-2ad0-4ef6-89e6-0f84c39542b6100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN34f7e401-9b2c-7d63-e063-6394a90a1f00100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN836ec7f1-e739-4b85-bb52-08d5c5ed4c11100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD34f7e401-9b2c-7d63-e063-6394a90a1f00100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2a869704-2ad0-4ef6-89e6-0f84c39542b6100
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD836ec7f1-e739-4b85-bb52-08d5c5ed4c11100
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN98a1c161-5728-4626-a6b0-5414935e4eef43
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD98a1c161-5728-4626-a6b0-5414935e4eef43
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYc38cfd32-2562-4d6c-8a2e-d9984c16d9eb36
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN53153595-41b9-4b2d-8b7d-0ffd29fdd1d833
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD53153595-41b9-4b2d-8b7d-0ffd29fdd1d833
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2e59dc14-7e17-4663-bc1f-7ee8e104dbfa20
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2e59dc14-7e17-4663-bc1f-7ee8e104dbfa20
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN6432d1aa-1e73-469e-835b-43d518963f7118
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD6432d1aa-1e73-469e-835b-43d518963f7118
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNaee7c4a8-10cb-2107-e053-2995a90a90e75
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN54af47cd-65c2-4bc9-95cd-7883e56ed0355
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8a7084e0-530c-607b-e053-2a95a90a229c5
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDaee7c4a8-10cb-2107-e053-2995a90a90e75
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD54af47cd-65c2-4bc9-95cd-7883e56ed0355
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8a7084e0-530c-607b-e053-2a95a90a229c5
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf99da162-f224-1c19-e053-6294a90acffb3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf99da162-f224-1c19-e053-6294a90acffb3
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc29f005e-ae75-415d-9fd6-591f074dcda52
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf563aa1a-1e21-49d4-e053-2a95a90a32642
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc29f005e-ae75-415d-9fd6-591f074dcda52
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf563aa1a-1e21-49d4-e053-2a95a90a32642
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN2879c79f-bf2f-0bc9-e063-6394a90a98ae1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNa500445c-0fa4-65ea-e053-2995a90a6c1a1
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNc1ef1319-7cd9-4420-8c33-24d2da38a6621
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff75226-d194-4d64-bcbb-d7d79f5d230e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDa500445c-0fa4-65ea-e053-2995a90a6c1a1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD2879c79f-bf2f-0bc9-e063-6394a90a98ae1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDc1ef1319-7cd9-4420-8c33-24d2da38a6621
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff75226-d194-4d64-bcbb-d7d79f5d230e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0674-0100185067401100 CAPSULE in 1 BOTTLE (0185-0674-01) 100 capsule2014-06-270000-00-00NoNoCurrent
0185-0674-0500185067405500 CAPSULE in 1 BOTTLE (0185-0674-05) 500 capsule2014-06-270000-00-00NoNoCurrent
0185-0674-10001850674101000 CAPSULE in 1 BOTTLE (0185-0674-10) 1000 capsule2014-06-270000-00-00NoNoCurrent