FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
71335-1923
11-digit product format
713351923
Labeler code
71335
Product ID
71335-1923_7142bcf3-e30c-41ec-824a-a9f4f0041046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1923-1Hydroxyzine Pamoate30 in 1 BOTTLE, PLASTICCAPSULE30103
71335-1923-2Hydroxyzine Pamoate60 in 1 BOTTLE, PLASTICCAPSULE60103
71335-1923-3Hydroxyzine Pamoate90 in 1 BOTTLE, PLASTICCAPSULE90103
71335-1923-4Hydroxyzine Pamoate8 in 1 BOTTLE, PLASTICCAPSULE8103
71335-1923-5Hydroxyzine Pamoate20 in 1 BOTTLE, PLASTICCAPSULE20103
71335-1923-6Hydroxyzine Pamoate42 in 1 BOTTLE, PLASTICCAPSULE42103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1923HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20231128_4ea3336a-2cc8-4e43-bc55-455fca67976e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1923-17133519230130 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-1) 30 capsule2022-01-200000-00-00NoNoCurrent
71335-1923-27133519230260 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-2) 60 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-37133519230390 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-3) 90 capsule2022-01-110000-00-00NoNoCurrent
71335-1923-4713351923048 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-4) 8 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-57133519230520 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-5) 20 capsule2022-02-140000-00-00NoNoCurrent
71335-1923-67133519230642 CAPSULE in 1 BOTTLE, PLASTIC (71335-1923-6) 42 capsule2022-02-140000-00-00NoNoCurrent