Hydroxyzine hydrochloride

Product NDC
33261-161
11-digit product format
332610161
Labeler code
33261
Product ID
33261-161_378b331a-5db3-40e2-b671-84528f371c2c
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
25 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
33261-161-152020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only
33261-161-202020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only
33261-161-302020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only
33261-161-402020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only
33261-161-602020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only
33261-161-902020-01-31C16284748780-19d75b9d0-8266-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-161-15Hydroxyzine hydrochloride15 in 1 BOTTLETABLET151
33261-161-20Hydroxyzine hydrochloride20 in 1 BOTTLETABLET201
33261-161-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET301
33261-161-40Hydroxyzine hydrochloride40 in 1 BOTTLETABLET401
33261-161-60Hydroxyzine hydrochloride60 in 1 BOTTLETABLET601
33261-161-90Hydroxyzine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-161-15EA - Each33261-1614e5cbbdd-bcf4-49cf-b0f8-2ede9e67353c12017-04-05
33261-161-20EA - Each33261-161e9d0bc81-1e76-49a9-8f56-1ba3d650b84912017-04-05
33261-161-30EA - Each33261-16100832f7d-40eb-46b0-8557-298d4ee21ca612017-04-05
33261-161-40EA - Each33261-161e3bfadad-79fb-483d-b530-1f3ed0e66a7a12017-04-05
33261-161-60EA - Each33261-161242930c7-324f-47bd-b41c-56cffc5a2a6412017-04-05
33261-161-90EA - Each33261-161b91e565e-20e9-4d05-bb71-5518620c951612017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-161HYDROXYZINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20170309_3a61627a-7ef8-495a-b798-6774eb38633a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN3a61627a-7ef8-495a-b798-6774eb38633a1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3a61627a-7ef8-495a-b798-6774eb38633a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-161-153326101611515 in 1 BOTTLEHistorical
33261-161-203326101612020 in 1 BOTTLEHistorical
33261-161-303326101613030 in 1 BOTTLEHistorical
33261-161-403326101614040 in 1 BOTTLEHistorical
33261-161-603326101616060 in 1 BOTTLEHistorical
33261-161-903326101619090 in 1 BOTTLEHistorical