Hydroxyzine Pamoate

Product NDC
53808-0429
11-digit product format
538080429
Labeler code
53808
Product ID
53808-0429_7896d94e-463d-41ff-8ac0-0680c8c857df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE PAMOATE
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040156
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
HYDROXYZINE PAMOATE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
53808-0429-12019-10-21C16284748780-1956f9ecf-d98f-621f-e053-dbdaa90a74adHydrOXYzine Pamoate Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0429-1Hydroxyzine Pamoate30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0429HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_af6f0641-7030-4d25-aca2-bd50c3827643.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNaf6f0641-7030-4d25-aca2-bd50c38276431
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNaf6f0641-7030-4d25-aca2-bd50c38276431
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDaf6f0641-7030-4d25-aca2-bd50c38276431
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDaf6f0641-7030-4d25-aca2-bd50c38276431
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYaf6f0641-7030-4d25-aca2-bd50c38276431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0429-15380804290130 in 1 BLISTER PACKHistorical