FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
0904-6618
11-digit product format
009046618
Labeler code
0904
Product ID
0904-6618_f78ac709-6b0b-438b-8333-bd4a7509cfed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040604
Marketing category
ANDA
Marketing start
2015-03-31
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
Rxcui995258, 995281

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
0904-6618-612022-02-03C16284748780-1d6a99b39-3680-a426-e053-dadaa90af4c2Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
0904-6618-612022-01-28C16284748780-1d6a99b39-3680-a426-e053-dadaa90af4c2Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6618-61Hydroxyzine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED110
0904-6618-61Hydroxyzine Hydrochloride100 in 1 CARTONTABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6618-61EA - Each0904-6618af3708b1-cc5b-40cf-ba8d-e4bfd013285512018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6618HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 2 package rows20250430_7534a3bb-b4cd-415f-8612-53b37dc6d55f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995281hydrOXYzine HCl 50 MG Oral TabletPSN7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7534a3bb-b4cd-415f-8612-53b37dc6d55f10
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD7534a3bb-b4cd-415f-8612-53b37dc6d55f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6618-6100904661861100 BLISTER PACK in 1 CARTON (0904-6618-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2015-03-310000-00-00NoNoCurrent