Hydroxyzine Pamoate

Product NDC
70518-2769
11-digit product format
705182769
Labeler code
70518
Product ID
70518-2769_4a8f5c13-54fe-3555-e063-6394a90ad9fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088488
Marketing category
ANDA
Marketing start
2020-06-08
Substance
HYDROXYZINE PAMOATE
Active strength
100 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 PAMOATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM20215MUFR
Rxcui995232

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2769-0Hydroxyzine Pamoate30 in 1 BLISTER PACKCAPSULE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2769HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 1 package rows20250402_a21df116-501f-4818-ad10-ccfa7b03d7ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995232hydrOXYzine pamoate 100 MG Oral CapsulePSNa21df116-501f-4818-ad10-ccfa7b03d7ad9
995232hydroxyzine pamoate 100 MG Oral CapsuleSCDa21df116-501f-4818-ad10-ccfa7b03d7ad9
995232hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral CapsuleSYa21df116-501f-4818-ad10-ccfa7b03d7ad9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2769-07051827690030 CAPSULE in 1 BLISTER PACK (70518-2769-0) 30 capsule2020-06-080000-00-00NoNoCurrent