Hydroxyzine hydrochloride

Product NDC
53217-225
11-digit product format
532170225
Labeler code
53217
Product ID
53217-225_e2984f05-4901-4976-9a71-f99381471f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-225-252020-01-31C16284748780-19d75b9d0-8e96-f424-e053-dadaa90a57ceRx only
53217-225-302020-01-31C16284748780-19d75b9d0-8e96-f424-e053-dadaa90a57ceRx only
53217-225-372020-01-31C16284748780-19d75b9d0-8e96-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-225-25Hydroxyzine hydrochloride25 in 1 BOTTLETABLET251
53217-225-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET301
53217-225-37Hydroxyzine hydrochloride17 in 1 BOTTLETABLET171

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-225-25EA - Each53217-2256d989016-8103-4d5c-9596-a5a082259c0a12016-12-07
53217-225-30EA - Each53217-225f8d5e03f-2da8-43de-be9a-96db17b100f212016-12-07
53217-225-37EA - Each53217-225a7f6cd49-3c29-4ca4-9820-00e70f5ca62612016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-225HYDROXYZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20161115_953bc2f8-00e6-4a5a-970e-64c048a2559f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSN953bc2f8-00e6-4a5a-970e-64c048a2559f1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD953bc2f8-00e6-4a5a-970e-64c048a2559f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-225-255321702252525 in 1 BOTTLEHistorical
53217-225-305321702253030 in 1 BOTTLEHistorical
53217-225-375321702253717 in 1 BOTTLEHistorical