FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
70518-4170
11-digit product format
705184170
Labeler code
70518
Product ID
70518-4170_4f09fd7b-ff49-513a-e063-6294a90a415e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217652
Marketing category
ANDA
Marketing start
2024-08-28
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROXYZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995281

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
70518-4170-0HYDROXYZINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-4170-1HYDROXYZINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908
70518-4170-2HYDROXYZINE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-4170-3HYDROXYZINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED608
70518-4170-4HYDROXYZINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908
70518-4170-5HYDROXYZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4170HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 6 package rows20250406_f6ad4729-b291-42c4-8483-99385d8043db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995281hydrOXYzine HCl 50 MG Oral TabletPSNf6ad4729-b291-42c4-8483-99385d8043db8
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDf6ad4729-b291-42c4-8483-99385d8043db8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4170-07051841700030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4170-0) 2024-08-28NoNoCurrent
70518-4170-17051841700190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-1) 2025-04-04NoNoCurrent
70518-4170-27051841700230 TABLET, FILM COATED in 1 BLISTER PACK (70518-4170-2) 2025-07-08NoNoCurrent
70518-4170-37051841700360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-3) 2025-10-24NoNoCurrent
70518-4170-47051841700490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-4) 2025-12-22NoNoCurrent
70518-4170-57051841700530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-5) 2026-04-09NoNoCurrent