FDA.reportPublic FDA data

Hydroxyzine pamoate

Product NDC
71335-2076
11-digit product format
713352076
Labeler code
71335
Product ID
71335-2076_b0f3980d-4810-4ae5-a4ea-11eddb1641f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086183
Marketing category
ANDA
Marketing start
1981-12-14
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
71335-2076-1Hydroxyzine pamoate30 in 1 BOTTLECAPSULE30102
71335-2076-2Hydroxyzine pamoate60 in 1 BOTTLECAPSULE60102
71335-2076-3Hydroxyzine pamoate90 in 1 BOTTLECAPSULE90102
71335-2076-4Hydroxyzine pamoate8 in 1 BOTTLECAPSULE8102
71335-2076-5Hydroxyzine pamoate20 in 1 BOTTLECAPSULE20102
71335-2076-6Hydroxyzine pamoate42 in 1 BOTTLECAPSULE42102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2076HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20231128_8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2076-17133520760130 CAPSULE in 1 BOTTLE (71335-2076-1) 30 capsule2022-04-250000-00-00NoNoCurrent
71335-2076-27133520760260 CAPSULE in 1 BOTTLE (71335-2076-2) 60 capsule2022-04-250000-00-00NoNoCurrent
71335-2076-37133520760390 CAPSULE in 1 BOTTLE (71335-2076-3) 90 capsule2022-04-250000-00-00NoNoCurrent
71335-2076-4713352076048 CAPSULE in 1 BOTTLE (71335-2076-4) 8 capsule2022-04-250000-00-00NoNoCurrent
71335-2076-57133520760520 CAPSULE in 1 BOTTLE (71335-2076-5) 20 capsule2022-04-250000-00-00NoNoCurrent
71335-2076-67133520760642 CAPSULE in 1 BOTTLE (71335-2076-6) 42 capsule2022-04-250000-00-00NoNoCurrent