FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
71205-558
11-digit product format
712050558
Labeler code
71205
Product ID
71205-558_bff75226-d194-4d64-bcbb-d7d79f5d230e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-558-30hydroxyzine pamoate30 in 1 BOTTLECAPSULE301
71205-558-60hydroxyzine pamoate60 in 1 BOTTLECAPSULE601
71205-558-90hydroxyzine pamoate90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-558-30EA - Each71205-558cf8a605a-90a0-4f4e-b0f5-675508badc2312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-558HYDROXYZINE PAMOATE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20210520_bff75226-d194-4d64-bcbb-d7d79f5d230e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff75226-d194-4d64-bcbb-d7d79f5d230e1
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff75226-d194-4d64-bcbb-d7d79f5d230e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-558-307120505583030 CAPSULE in 1 BOTTLE (71205-558-30) 30 capsule2021-05-030000-00-00NoNoCurrent
71205-558-607120505586060 CAPSULE in 1 BOTTLE (71205-558-60) 60 capsule2021-05-030000-00-00NoNoCurrent
71205-558-907120505589090 CAPSULE in 1 BOTTLE (71205-558-90) 90 capsule2021-05-030000-00-00NoNoCurrent