FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
63187-733
11-digit product format
631870733
Labeler code
63187
Product ID
63187-733_edabc25f-0f5d-42c1-8edc-b3e5bcc4dd45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204279
Marketing category
ANDA
Marketing start
2012-03-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 DIHYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995258

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
63187-733-20Hydroxyzine hydrochloride20 in 1 BOTTLETABLET206
63187-733-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET306
63187-733-60Hydroxyzine hydrochloride60 in 1 BOTTLETABLET606
63187-733-90Hydroxyzine hydrochloride90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-733-20EA - Each63187-7330745ed86-0bf5-4e2f-a0f8-f16f0cf6a1cf12017-04-05
63187-733-30EA - Each63187-73379671370-98cd-400b-b08e-3d7a71e18b3f12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-733HYDROXYZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220612_83e8d60d-36fd-4223-b50c-e6615045352a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN83e8d60d-36fd-4223-b50c-e6615045352a6
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD83e8d60d-36fd-4223-b50c-e6615045352a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-733-206318707332020 TABLET in 1 BOTTLE (63187-733-20) 20 tablet2017-01-020000-00-00NoNoCurrent
63187-733-306318707333030 TABLET in 1 BOTTLE (63187-733-30) 30 tablet2016-07-010000-00-00NoNoCurrent
63187-733-606318707336060 TABLET in 1 BOTTLE (63187-733-60) 60 tablet2016-07-010000-00-00NoNoCurrent
63187-733-906318707339090 TABLET in 1 BOTTLE (63187-733-90) 90 tablet2016-07-010000-00-00NoNoCurrent