FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71335-1325
11-digit product format
713351325
Labeler code
71335
Product ID
71335-1325_fc20de76-1328-4c44-a143-d25ec5845187
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1325-1hydroxyzine pamoate20 in 1 BOTTLECAPSULE20106
71335-1325-2hydroxyzine pamoate30 in 1 BOTTLECAPSULE30106
71335-1325-3hydroxyzine pamoate100 in 1 BOTTLECAPSULE100106
71335-1325-4hydroxyzine pamoate10 in 1 BOTTLECAPSULE10106
71335-1325-5hydroxyzine pamoate15 in 1 BOTTLECAPSULE15106
71335-1325-6hydroxyzine pamoate60 in 1 BOTTLECAPSULE60106
71335-1325-7hydroxyzine pamoate90 in 1 BOTTLECAPSULE90106
71335-1325-8hydroxyzine pamoate120 in 1 BOTTLECAPSULE120106
71335-1325-9hydroxyzine pamoate42 in 1 BOTTLECAPSULE42106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1325HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 9 package rows20240526_7996dfa3-7f34-4d20-acaa-7f6fc021fc80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN7996dfa3-7f34-4d20-acaa-7f6fc021fc80106
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD7996dfa3-7f34-4d20-acaa-7f6fc021fc80106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1325-17133513250120 CAPSULE in 1 BOTTLE (71335-1325-1) 20 capsule2019-08-280000-00-00NoNoCurrent
71335-1325-27133513250230 CAPSULE in 1 BOTTLE (71335-1325-2) 30 capsule2019-08-280000-00-00NoNoCurrent
71335-1325-371335132503100 CAPSULE in 1 BOTTLE (71335-1325-3) 100 capsule2022-09-190000-00-00NoNoCurrent
71335-1325-47133513250410 CAPSULE in 1 BOTTLE (71335-1325-4) 10 capsule2022-09-190000-00-00NoNoCurrent
71335-1325-57133513250515 CAPSULE in 1 BOTTLE (71335-1325-5) 15 capsule2022-09-190000-00-00NoNoCurrent
71335-1325-67133513250660 CAPSULE in 1 BOTTLE (71335-1325-6) 60 capsule2021-12-220000-00-00NoNoCurrent
71335-1325-77133513250790 CAPSULE in 1 BOTTLE (71335-1325-7) 90 capsule2021-09-300000-00-00NoNoCurrent
71335-1325-871335132508120 CAPSULE in 1 BOTTLE (71335-1325-8) 120 capsule2022-09-190000-00-00NoNoCurrent
71335-1325-97133513250942 CAPSULE in 1 BOTTLE (71335-1325-9) 42 capsule2022-09-190000-00-00NoNoCurrent