FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
16571-113
11-digit product format
165710113
Labeler code
16571
Product ID
16571-113_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
10 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 DIHYDROCHLORIDE10 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
16571-113-01HYDROXYZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1003
16571-113-50HYDROXYZINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-113HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241031_6a1a48ac-8ad5-4363-b298-d9825ae2a448.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
995218hydrOXYzine HCl 10 MG Oral TabletPSN6577589f-1a80-41d8-847a-70c3f38d8dc01
995218hydrOXYzine HCl 10 MG Oral TabletPSNa35d1fe2-328d-42ff-ba1f-18a7f2f03c881
995218hydrOXYzine HCl 10 MG Oral TabletPSNca843456-0c93-41e8-9bbc-9cd92447f0921
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD6577589f-1a80-41d8-847a-70c3f38d8dc01
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDa35d1fe2-328d-42ff-ba1f-18a7f2f03c881
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDca843456-0c93-41e8-9bbc-9cd92447f0921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16571-113-0116571011301100 TABLET, FILM COATED in 1 BOTTLE (16571-113-01) 2023-08-22NoNoCurrent
16571-113-5016571011350500 TABLET, FILM COATED in 1 BOTTLE (16571-113-50) 2023-08-22NoNoCurrent