HYDROXYZINE PAMOATE

Product NDC
61919-352
11-digit product format
619190352
Labeler code
61919
Product ID
61919-352_9c9737dd-859f-1f12-e053-2a95a90ac898
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA201507
Marketing category
ANDA
Marketing start
2017-02-08
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-352-302023-01-30C16284748780-1f386c64a-1116-0266-e053-dadaa90a7c1aHYDROXYZINE PAMOATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-352-30HYDROXYZINE PAMOATE30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-352HYDROXYZINE PAMOATE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20200121_480add5c-5f90-69d8-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN480add5c-5f90-69d8-e054-00144ff88e882
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD480add5c-5f90-69d8-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-352-306191903523030 CAPSULE in 1 BOTTLE (61919-352-30) 30 capsule2017-02-080000-00-00NoNoCurrent