hydroxyzine pamoate

Product NDC
51655-847
11-digit product format
516550847
Labeler code
51655
Product ID
51655-847_4973e097-062d-29f5-e063-6294a90ae952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA087479
Marketing category
ANDA
Marketing start
2023-04-10
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
hydroxyzine pamoate
Listing expiration
2027-12-31

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
51655-847-20hydroxyzine pamoate20 in 1 BOTTLE, PLASTICCAPSULE203
51655-847-52hydroxyzine pamoate30 in 1 BOTTLE, PLASTICCAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-847HYDROXYZINE PAMOATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230630_f99da162-f224-1c19-e053-6294a90acffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNf99da162-f224-1c19-e053-6294a90acffb3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDf99da162-f224-1c19-e053-6294a90acffb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-847-205165508472020 CAPSULE in 1 BOTTLE, PLASTIC (51655-847-20) 20 capsule2023-04-10NoNoHistorical
51655-847-525165508475230 CAPSULE in 1 BOTTLE, PLASTIC (51655-847-52) 30 capsule2023-05-03NoNoHistorical