HYDROXYZINE PAMOATE

Product NDC
61919-121
11-digit product format
619190121
Labeler code
61919
Product ID
61919-121_c3e03adf-778b-5581-e053-2995a90aad4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA201507
Marketing category
ANDA
Marketing start
2017-04-14
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
2022-12-31
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
61919-121-152023-01-30C16284748780-1f386c64a-19da-0266-e053-dadaa90a7c1aHYDROXYZINE PAMOATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-121-15HYDROXYZINE PAMOATE15 in 1 BOTTLECAPSULE153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-121HYDROXYZINE PAMOATE CAPSULE [DIRECT RX]3Legacy NDC, 1 package rows20210604_4d226b9a-bd9b-4bc0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydrOXYzine pamoate 50 MG Oral CapsulePSN4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995253hydroxyzine pamoate 25 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydroxyzine pamoate 50 MG Oral CapsuleSCD4d226b9a-bd9b-4bc0-e054-00144ff8d46c3
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSY4d226b9a-bd9b-4bc0-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-121-156191901211515 CAPSULE in 1 BOTTLE (61919-121-15) 15 capsule2017-04-140000-00-00NoNoCurrent