FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
70518-2279
11-digit product format
705182279
Labeler code
70518
Product ID
70518-2279_49f0ba74-62af-655f-e063-6294a90a9f99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA088618
Marketing category
ANDA
Marketing start
2019-08-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 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
70518-2279-0Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2279-1Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2279-2Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016
70518-2279-3Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2279HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20250309_ca67c061-c743-4ebb-a9d5-ece488060663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNca67c061-c743-4ebb-a9d5-ece48806066316
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDca67c061-c743-4ebb-a9d5-ece48806066316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2279-07051822790030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2279-0) 2019-08-24NoNoCurrent
70518-2279-17051822790130 TABLET, FILM COATED in 1 BLISTER PACK (70518-2279-1) 2021-05-100000-00-00NoNoCurrent
70518-2279-27051822790230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2279-2) 2022-01-130000-00-00NoNoCurrent
70518-2279-37051822790330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2279-3) 2022-07-170000-00-00NoNoCurrent