FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
72789-216
11-digit product format
727890216
Labeler code
72789
Product ID
72789-216_3caab728-dec4-fe78-e063-6294a90a17ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
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
72789-216-04Hydroxyzine Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED423
72789-216-12Hydroxyzine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1223
72789-216-20Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023
72789-216-30Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
72789-216-40Hydroxyzine Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4023
72789-216-60Hydroxyzine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023
72789-216-90Hydroxyzine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-216HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 7 package rows20241011_2b05bd0e-af57-4e74-92f8-a4311330142f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN2b05bd0e-af57-4e74-92f8-a4311330142f23
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD2b05bd0e-af57-4e74-92f8-a4311330142f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-216-04727890216044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04) 2023-08-17NoNoCurrent
72789-216-127278902161212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12) 2022-02-140000-00-00NoNoCurrent
72789-216-207278902162020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20) 2022-03-240000-00-00NoNoCurrent
72789-216-307278902163030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30) 2021-11-300000-00-00NoNoCurrent
72789-216-407278902164040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40) 2021-11-180000-00-00NoNoCurrent
72789-216-607278902166060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60) 2022-06-240000-00-00NoNoCurrent
72789-216-907278902169090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90) 2021-12-080000-00-00NoNoCurrent