FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
17856-0507
11-digit product format
178560507
Labeler code
17856
Product ID
17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA201674
Marketing category
ANDA
Marketing start
2013-08-21
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
10 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76755771U3
Rxcui995241

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0507-12024-05-08C16284748780-11030e365-5e4e-111a-e063-dadaa90a10e2HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL Rx only
17856-0507-12024-01-30C16284748780-11030e365-5e4e-111a-e063-dadaa90a10e2HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0507-1Hydroxyzine Hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION725
17856-0507-2Hydroxyzine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0507HYDROXYZINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 2 package rows20250514_a2fbc502-6ca3-4304-9069-b7249c9d9489.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSNa2fbc502-6ca3-4304-9069-b7249c9d94895
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCDa2fbc502-6ca3-4304-9069-b7249c9d94895
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSYa2fbc502-6ca3-4304-9069-b7249c9d94895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0507-11785605070172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2) 2024-05-080000-00-00NoNoCurrent
17856-0507-2178560507025 mL in 1 CUP, UNIT-DOSE5 mlHistorical