FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
63187-354
11-digit product format
631870354
Labeler code
63187
Product ID
63187-354_10a1ea3e-48ca-4dd5-8808-a4be16048c3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995281

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-354-15Hydroxyzine hydrochloride15 in 1 BOTTLETABLET154
63187-354-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET304
63187-354-60Hydroxyzine hydrochloride60 in 1 BOTTLETABLET604
63187-354-90Hydroxyzine hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-354-30EA - Each63187-354b5a8d25c-c6fa-4def-971e-6721d5fcd74412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-354HYDROXYZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20220604_73993c7e-acd7-4835-be03-f8274a15955b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSN73993c7e-acd7-4835-be03-f8274a15955b4
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD73993c7e-acd7-4835-be03-f8274a15955b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-354-156318703541515 TABLET in 1 BOTTLE (63187-354-15) 15 tablet2016-08-010000-00-00NoNoCurrent
63187-354-306318703543030 TABLET in 1 BOTTLE (63187-354-30) 30 tablet2016-08-010000-00-00NoNoCurrent
63187-354-606318703546060 TABLET in 1 BOTTLE (63187-354-60) 60 tablet2016-08-010000-00-00NoNoCurrent
63187-354-906318703549090 TABLET in 1 BOTTLE (63187-354-90) 90 tablet2016-08-010000-00-00NoNoCurrent