FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
71610-851
11-digit product format
716100851
Labeler code
71610
Product ID
71610-851_a8284037-d6c6-4816-8469-0151f5761ae7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
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
71610-851-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET301
71610-851-53Hydroxyzine hydrochloride60 in 1 BOTTLETABLET601
71610-851-60Hydroxyzine hydrochloride90 in 1 BOTTLETABLET901
71610-851-70Hydroxyzine hydrochloride120 in 1 BOTTLETABLET1201
71610-851-80Hydroxyzine hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-851-30EA - Each71610-851bebf7de1-93fd-4f10-b3c0-a9c7c579819e12024-10-04
71610-851-53EA - Each71610-85115ed356d-edd0-49b0-8fc4-bd0eb5b0993e12024-10-04
71610-851-60EA - Each71610-85186de4ef3-b1b5-4b9d-9f88-9a083dcf435a12024-10-04
71610-851-70EA - Each71610-85102a4ca8a-cb42-4e55-bd5a-c322e330e68912024-10-04
71610-851-80EA - Each71610-851cf24136f-4ab3-41ee-847b-01b6e4b90b3b12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-851HYDROXYZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20240901_7b6ebf69-77d5-434f-81a4-3d5587fd431e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN7b6ebf69-77d5-434f-81a4-3d5587fd431e1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD7b6ebf69-77d5-434f-81a4-3d5587fd431e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-851-307161008513030 TABLET in 1 BOTTLE (71610-851-30) 30 tablet2024-08-22NoNoHistorical
71610-851-537161008515360 TABLET in 1 BOTTLE (71610-851-53) 60 tablet2024-08-22NoNoHistorical
71610-851-607161008516090 TABLET in 1 BOTTLE (71610-851-60) 90 tablet2024-08-22NoNoHistorical
71610-851-7071610085170120 TABLET in 1 BOTTLE (71610-851-70) 120 tablet2024-08-22NoNoHistorical
71610-851-8071610085180180 TABLET in 1 BOTTLE (71610-851-80) 180 tablet2024-08-22NoNoHistorical