FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71335-1714
11-digit product format
713351714
Labeler code
71335
Product ID
71335-1714_b80b0312-5c65-4bfd-a619-5a7c9ce6e3c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA087479
Marketing category
ANDA
Marketing start
1981-12-14
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
71335-1714-1hydroxyzine pamoate20 in 1 BOTTLECAPSULE20106
71335-1714-2hydroxyzine pamoate30 in 1 BOTTLECAPSULE30106
71335-1714-3hydroxyzine pamoate100 in 1 BOTTLECAPSULE100106
71335-1714-4hydroxyzine pamoate10 in 1 BOTTLECAPSULE10106
71335-1714-5hydroxyzine pamoate15 in 1 BOTTLECAPSULE15106
71335-1714-6hydroxyzine pamoate60 in 1 BOTTLECAPSULE60106
71335-1714-7hydroxyzine pamoate90 in 1 BOTTLECAPSULE90106
71335-1714-8hydroxyzine pamoate120 in 1 BOTTLECAPSULE120106
71335-1714-9hydroxyzine pamoate42 in 1 BOTTLECAPSULE42106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1714-2EA - Each71335-17148349e063-f849-47ed-adb1-bf0fd953e94012021-08-05
71335-1714-7EA - Each71335-1714ff8a6436-653f-470a-9cea-0bb41f39017712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1714HYDROXYZINE PAMOATE CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 9 package rows20250212_f74e4b3e-992c-402d-92b8-258fccb42b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf74e4b3e-992c-402d-92b8-258fccb42b64106
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf74e4b3e-992c-402d-92b8-258fccb42b64106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1714-17133517140120 CAPSULE in 1 BOTTLE (71335-1714-1) 20 capsule2021-05-070000-00-00NoNoCurrent
71335-1714-27133517140230 CAPSULE in 1 BOTTLE (71335-1714-2) 30 capsule2020-10-150000-00-00NoNoCurrent
71335-1714-371335171403100 CAPSULE in 1 BOTTLE (71335-1714-3) 100 capsule2021-12-290000-00-00NoNoCurrent
71335-1714-47133517140410 CAPSULE in 1 BOTTLE (71335-1714-4) 10 capsule2021-12-290000-00-00NoNoCurrent
71335-1714-57133517140515 CAPSULE in 1 BOTTLE (71335-1714-5) 15 capsule2021-12-290000-00-00NoNoCurrent
71335-1714-67133517140660 CAPSULE in 1 BOTTLE (71335-1714-6) 60 capsule2021-07-140000-00-00NoNoCurrent
71335-1714-77133517140790 CAPSULE in 1 BOTTLE (71335-1714-7) 90 capsule2021-03-190000-00-00NoNoCurrent
71335-1714-871335171408120 CAPSULE in 1 BOTTLE (71335-1714-8) 120 capsule2021-12-290000-00-00NoNoCurrent
71335-1714-97133517140942 CAPSULE in 1 BOTTLE (71335-1714-9) 42 capsule2021-12-290000-00-00NoNoCurrent