FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
16571-115
11-digit product format
165710115
Labeler code
16571
Product ID
16571-115_20aba551-c0c0-4ea1-8200-ad81956ff294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217652
Marketing category
ANDA
Marketing start
2023-08-22
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
50 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 DIHYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995218, 995258, 995281

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
16571-115-01HYDROXYZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1003
16571-115-10HYDROXYZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10003
16571-115-50HYDROXYZINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-115HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20241031_6a1a48ac-8ad5-4363-b298-d9825ae2a448.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
995218hydrOXYzine HCl 10 MG Oral TabletPSN6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995258hydrOXYzine HCl 25 MG Oral TabletPSN6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995281hydrOXYzine HCl 50 MG Oral TabletPSN6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD6a1a48ac-8ad5-4363-b298-d9825ae2a4483
995281hydrOXYzine HCl 50 MG Oral TabletPSN19b08f92-da63-021f-e063-6394a90a16e21
995281hydrOXYzine HCl 50 MG Oral TabletPSN22049012-733e-6b45-e063-6294a90a670f1
995281hydrOXYzine HCl 50 MG Oral TabletPSN4b8614d9-335c-4141-aaed-445c604ba08c1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD19b08f92-da63-021f-e063-6394a90a16e21
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD22049012-733e-6b45-e063-6294a90a670f1
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD4b8614d9-335c-4141-aaed-445c604ba08c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-115-0116571011501100 TABLET, FILM COATED in 1 BOTTLE (16571-115-01) 2023-08-22NoNoCurrent
16571-115-10165710115101000 TABLET, FILM COATED in 1 BOTTLE (16571-115-10) 2023-08-22NoNoCurrent
16571-115-5016571011550500 TABLET, FILM COATED in 1 BOTTLE (16571-115-50) 2023-08-22NoNoCurrent