FDA.reportPublic FDA data

HYDROXYZINE HYDROCHLORIDE

Product NDC
11534-204
11-digit product format
115340204
Labeler code
11534
Product ID
11534-204_4f0e9eea-4f47-49fe-a609-790dada173d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydroxyzine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sunrise Pharmaceutical, Inc.
Application
ANDA207121
Marketing category
ANDA
Marketing start
2024-04-16
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
11534-204-01HYDROXYZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007
11534-204-03HYDROXYZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10007
11534-204-04HYDROXYZINE HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-204-01EA - Each11534-204b625654f-ae03-4855-9eee-dcaff9e4baaa12024-08-12
11534-204-03EA - Each11534-2043913dfff-1a8c-43cf-b283-e18fed68714c12024-08-12
11534-204-04EA - Each11534-204e83243fb-8657-4efe-9d81-d7e0b0cd99d512026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-204HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [SUNRISE PHARMACEUTICAL, INC.]7Current NDC, 3 package rows20241211_94561525-a565-4193-b64d-e1459ab05678.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN94561525-a565-4193-b64d-e1459ab056787
995258hydrOXYzine HCl 25 MG Oral TabletPSN94561525-a565-4193-b64d-e1459ab056787
995281hydrOXYzine HCl 50 MG Oral TabletPSN94561525-a565-4193-b64d-e1459ab056787
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD94561525-a565-4193-b64d-e1459ab056787
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD94561525-a565-4193-b64d-e1459ab056787
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD94561525-a565-4193-b64d-e1459ab056787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11534-204-0111534020401100 TABLET, FILM COATED in 1 BOTTLE (11534-204-01) 2024-04-16NoNoHistorical
11534-204-03115340204031000 TABLET, FILM COATED in 1 BOTTLE (11534-204-03) 2024-04-16NoNoHistorical
11534-204-0411534020404500 TABLET, FILM COATED in 1 BOTTLE (11534-204-04) 2025-01-10NoNoHistorical