FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
60687-675
11-digit product format
606870675
Labeler code
60687
Product ID
60687-675_21b18b38-063e-eca0-e063-6294a90a6a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA088618
Marketing category
ANDA
Marketing start
2022-10-20
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 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 DIHYDROCHLORIDE25 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
60687-675-01Hydroxyzine Hydrochloride100 in 1 CARTONTABLET, FILM COATED1002
60687-675-11Hydroxyzine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-675-01EA - Each60687-6757ed281f4-ff3b-469b-a4ce-6e36b8330b9f12022-09-12
60687-675-11EA - Each60687-6756c35f975-a270-443a-98c9-f6c82c82400a12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-675HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240926_47bda4fe-ddb7-4140-900a-970373cc7acc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995281hydrOXYzine HCl 50 MG Oral TabletPSN47bda4fe-ddb7-4140-900a-970373cc7acc2
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD47bda4fe-ddb7-4140-900a-970373cc7acc2
995258hydrOXYzine HCl 25 MG Oral TabletPSNb4d274ce-d616-4835-80ce-76270524ed361
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDb4d274ce-d616-4835-80ce-76270524ed361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-675-0160687067501100 BLISTER PACK in 1 CARTON (60687-675-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-675-11) 100 blister pack2022-10-200000-00-00NoNoCurrent
60687-675-11606870675111 in 1 BLISTER PACKHistorical