FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71335-1265
11-digit product format
713351265
Labeler code
71335
Product ID
71335-1265_d9e2251d-75ed-4306-b75c-20e1b145f931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201507
Marketing category
ANDA
Marketing start
2013-06-03
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
Rxcui995278

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
71335-1265-12024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-22024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-32024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-42024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-52024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-62024-05-20C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-12024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-22024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-32024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-42024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-52024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only
71335-1265-62024-01-30C16284748780-11030e365-6f54-111a-e063-dadaa90a10e2Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1265-1hydroxyzine pamoate30 in 1 BOTTLECAPSULE306
71335-1265-2hydroxyzine pamoate60 in 1 BOTTLECAPSULE606
71335-1265-3hydroxyzine pamoate90 in 1 BOTTLECAPSULE906
71335-1265-4hydroxyzine pamoate8 in 1 BOTTLECAPSULE86
71335-1265-5hydroxyzine pamoate20 in 1 BOTTLECAPSULE206
71335-1265-6hydroxyzine pamoate42 in 1 BOTTLECAPSULE426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1265HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 6 package rows20240522_dde576e9-fb6b-40d2-a81f-ebb8656c4c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYdde576e9-fb6b-40d2-a81f-ebb8656c4c9c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1265-17133512650130 CAPSULE in 1 BOTTLE (71335-1265-1) 30 capsule2019-07-290000-00-00NoNoCurrent
71335-1265-27133512650260 CAPSULE in 1 BOTTLE (71335-1265-2) 60 capsule2024-05-170000-00-00NoNoCurrent
71335-1265-37133512650390 CAPSULE in 1 BOTTLE (71335-1265-3) 90 capsule2024-05-170000-00-00NoNoCurrent
71335-1265-4713351265048 CAPSULE in 1 BOTTLE (71335-1265-4) 8 capsule2024-05-170000-00-00NoNoCurrent
71335-1265-57133512650520 CAPSULE in 1 BOTTLE (71335-1265-5) 20 capsule2019-06-240000-00-00NoNoCurrent
71335-1265-67133512650642 CAPSULE in 1 BOTTLE (71335-1265-6) 42 capsule2020-01-060000-00-00NoNoCurrent