FDA.reportPublic FDA data

Hydroxyzine Pamoate

Product NDC
71610-217
11-digit product format
716100217
Labeler code
71610
Product ID
71610-217_6b2afb94-dcdd-40b9-9d0b-eec36d08e42c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040156
Marketing category
ANDA
Marketing start
1996-07-15
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
71610-217-30Hydroxyzine Pamoate30 in 1 BOTTLE, PLASTICCAPSULE302
71610-217-53Hydroxyzine Pamoate60 in 1 BOTTLE, PLASTICCAPSULE602
71610-217-60Hydroxyzine Pamoate90 in 1 BOTTLE, PLASTICCAPSULE902
71610-217-70Hydroxyzine Pamoate120 in 1 BOTTLE, PLASTICCAPSULE1202
71610-217-80Hydroxyzine Pamoate180 in 1 BOTTLE, PLASTICCAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-217-30EA - Each71610-2176a248855-9842-45d5-af99-b01284731d8712021-11-09
71610-217-53EA - Each71610-21729b23fec-637a-4727-92bf-d2aef27c6ab812021-11-09
71610-217-60EA - Each71610-2177031766b-85bd-4eb9-8d58-7cb60f04dc5012019-02-13
71610-217-70EA - Each71610-217aee05fe8-4843-4610-aede-d55b560baaa612021-11-09
71610-217-80EA - Each71610-217c86d0307-5994-4add-a120-54f023291d1612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-217HYDROXYZINE PAMOATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20211017_d6a1df2e-c111-4ee7-9d56-469db19b7c60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNd6a1df2e-c111-4ee7-9d56-469db19b7c602
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDd6a1df2e-c111-4ee7-9d56-469db19b7c602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-217-307161002173030 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-30) 30 capsule2021-09-090000-00-00NoNoCurrent
71610-217-537161002175360 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-53) 60 capsule2021-09-090000-00-00NoNoCurrent
71610-217-607161002176090 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-60) 90 capsule2019-01-070000-00-00NoNoCurrent
71610-217-7071610021770120 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-70) 120 capsule2021-09-090000-00-00NoNoCurrent
71610-217-8071610021780180 CAPSULE in 1 BOTTLE, PLASTIC (71610-217-80) 180 capsule2021-09-090000-00-00NoNoCurrent