FDA.reportPublic FDA data

hydroxyzine pamoate

Product NDC
68788-8119
11-digit product format
687888119
Labeler code
68788
Product ID
68788-8119_750aba1a-3d3e-4f51-a9f0-b0eb404925fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA087479
Marketing category
ANDA
Marketing start
2021-12-13
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
68788-8119-1hydroxyzine pamoate100 in 1 BOTTLECAPSULE1005
68788-8119-3hydroxyzine pamoate30 in 1 BOTTLECAPSULE305
68788-8119-5hydroxyzine pamoate15 in 1 BOTTLECAPSULE155
68788-8119-6hydroxyzine pamoate60 in 1 BOTTLECAPSULE605
68788-8119-9hydroxyzine pamoate90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8119-1EA - Each68788-8119a89c8409-1e83-4e1b-a36a-3a3d4a5d7b0a12022-02-07
68788-8119-3EA - Each68788-81196ee8ae0f-1657-4f05-9277-67137345f41112022-02-07
68788-8119-5EA - Each68788-81195f95e702-b539-43b6-bc03-00060ef72b2012022-02-07
68788-8119-6EA - Each68788-8119d9923961-343e-44e8-b1d4-ccf821ba26ce12022-02-07
68788-8119-9EA - Each68788-8119093a34b2-da44-4530-83c0-3336d22b858612022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8119HYDROXYZINE PAMOATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 5 package rows20240524_54af47cd-65c2-4bc9-95cd-7883e56ed035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN54af47cd-65c2-4bc9-95cd-7883e56ed0355
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD54af47cd-65c2-4bc9-95cd-7883e56ed0355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8119-168788811901100 CAPSULE in 1 BOTTLE (68788-8119-1) 100 capsule2021-12-130000-00-00NoNoCurrent
68788-8119-36878881190330 CAPSULE in 1 BOTTLE (68788-8119-3) 30 capsule2021-12-130000-00-00NoNoCurrent
68788-8119-56878881190515 CAPSULE in 1 BOTTLE (68788-8119-5) 15 capsule2021-12-130000-00-00NoNoCurrent
68788-8119-66878881190660 CAPSULE in 1 BOTTLE (68788-8119-6) 60 capsule2021-12-130000-00-00NoNoCurrent
68788-8119-96878881190990 CAPSULE in 1 BOTTLE (68788-8119-9) 90 capsule2021-12-130000-00-00NoNoCurrent