Hydroxyzine Pamoate

Product NDC
72189-009
11-digit product format
721890009
Labeler code
72189
Product ID
72189-009_2c4e7a35-ff56-4971-e063-6294a90ae9df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201507
Marketing category
ANDA
Marketing start
2019-06-26
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

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
72189-009-302024-01-30C16284748780-11030e365-5ecb-111a-e063-dadaa90a10e2Hydroxyzine Pamoate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-009-15Hydroxyzine Pamoate15 in 1 BOTTLECAPSULE154
72189-009-60Hydroxyzine Pamoate60 in 1 BOTTLECAPSULE604
72189-009-30Hydroxyzine Pamoate30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-009HYDROXYZINE PAMOATE CAPSULE [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20250123_8c395a13-9da3-7b77-e053-2995a90a1916.zip
72189-009HYDROXYZINE PAMOATE CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190626_8c397c3f-d51b-c3ef-e053-2995a90a8eb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8c395a13-9da3-7b77-e053-2995a90a19164
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8c395a13-9da3-7b77-e053-2995a90a19164
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN8c397c3f-d51b-c3ef-e053-2995a90a8eb51
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD8c397c3f-d51b-c3ef-e053-2995a90a8eb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-009-157218900091515 CAPSULE in 1 BOTTLE (72189-009-15) 15 capsule2019-06-260000-00-00NoNoCurrent
72189-009-307218900093030 CAPSULE in 1 BOTTLE (72189-009-30) 30 capsule2019-06-260000-00-00NoNoCurrent
72189-009-607218900096060 CAPSULE in 1 BOTTLE (72189-009-60) 60 capsule2019-06-260000-00-00NoNoCurrent