FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
72162-1333
11-digit product format
721621333
Labeler code
72162
Product ID
72162-1333_df71fb38-abdf-48a7-b77a-220a3a32d166
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
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
72162-1333-2Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20103
72162-1333-3Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30103
72162-1333-4Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15103
72162-1333-5Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED500103
72162-1333-6Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60103
72162-1333-8Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED10103
72162-1333-9Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1333-2EA - Each72162-133307ca320a-3175-4c0f-a293-1eb97016cf0f12023-10-16
72162-1333-3EA - Each72162-13333318cd39-8225-46b2-aec3-b41bb74d653412023-10-16
72162-1333-4EA - Each72162-1333f0fc71f7-0e88-447e-8ef3-08add69448c912023-10-16
72162-1333-5EA - Each72162-1333e603493c-d093-4c3f-ba29-14611b43fb3a12024-02-14
72162-1333-6EA - Each72162-1333a6762394-0afc-4dd3-bde1-1ae317524c2812023-10-16
72162-1333-8EA - Each72162-13334d452123-4236-4f77-ab09-6fb696eba74812023-10-16
72162-1333-9EA - Each72162-1333c817e215-d073-4942-ba4a-41e17f9336ed12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1333HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 7 package rows20250409_d03fdfd0-5dbd-40fe-a6e3-082a47751c2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNd03fdfd0-5dbd-40fe-a6e3-082a47751c2c103
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd03fdfd0-5dbd-40fe-a6e3-082a47751c2c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1333-27216213330220 TABLET, FILM COATED in 1 BOTTLE (72162-1333-2) 2024-04-08NoNoHistorical
72162-1333-37216213330330 TABLET, FILM COATED in 1 BOTTLE (72162-1333-3) 2024-04-08NoNoHistorical
72162-1333-47216213330415 TABLET, FILM COATED in 1 BOTTLE (72162-1333-4) 2024-04-08NoNoHistorical
72162-1333-572162133305500 TABLET, FILM COATED in 1 BOTTLE (72162-1333-5) 2024-04-08NoNoHistorical
72162-1333-67216213330660 TABLET, FILM COATED in 1 BOTTLE (72162-1333-6) 2024-04-08NoNoHistorical
72162-1333-87216213330810 TABLET, FILM COATED in 1 BOTTLE (72162-1333-8) 2024-04-08NoNoHistorical
72162-1333-97216213330990 TABLET, FILM COATED in 1 BOTTLE (72162-1333-9) 2024-04-08NoNoHistorical