Hydroxyzine Hydrochloride

Product NDC
17856-0150
11-digit product format
178560150
Labeler code
17856
Product ID
17856-0150_7e8e68b5-852c-4bc0-b9a9-f32772ee3dc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA087294
Marketing category
ANDA
Marketing start
1995-03-09
Marketing end
0000-00-00
Substance
HYDROXYZINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0150-12023-01-30C16284748780-1f386c649-9ffb-0266-e053-dadaa90a7c1aHYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP (SYRUP) 10 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0150-1Hydroxyzine Hydrochloride5 mL in 1 CUPSYRUP54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0150HYDROXYZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 1 package rows20210128_25609c5f-953f-4434-938a-e3f01069893e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995241hydrOXYzine HCl 10 MG in 5 mL Oral SolutionPSN25609c5f-953f-4434-938a-e3f01069893e4
995241hydroxyzine hydrochloride 2 MG/ML Oral SolutionSCD25609c5f-953f-4434-938a-e3f01069893e4
995241hydroxyzine hydrochloride 10 MG per 5 ML Oral SolutionSY25609c5f-953f-4434-938a-e3f01069893e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0150-1178560150015 mL in 1 CUP (17856-0150-1) 5 ml2021-01-270000-00-00NoNoCurrent