FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71205-155
11-digit product format
712050155
Labeler code
71205
Product ID
71205-155_638d968a-83ac-4947-9414-5f910087297f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA088618
Marketing category
ANDA
Marketing start
2012-10-09
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
Rxcui995258

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
71205-155-10Hydroxyzine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED107
71205-155-16Hydroxyzine Hydrochloride16 in 1 BOTTLETABLET, FILM COATED167
71205-155-20Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
71205-155-30Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
71205-155-60Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-155-10EA - Each71205-155b6923152-0b3f-4071-8301-f01227f2781312024-06-10
71205-155-16EA - Each71205-1550fcf5ad6-9613-4f54-a9de-ff1bf725a41b12023-04-07
71205-155-20EA - Each71205-15582b51aa1-31d1-489f-82df-701968afbeef12019-02-13
71205-155-30EA - Each71205-155338f4c65-917a-4dd1-b9ac-2e1762cf543b12019-04-11
71205-155-60EA - Each71205-15508a19e03-9202-4369-909e-7baf170c66c312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-155HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20240517_d79be126-39cd-4dbb-ad88-0e4c18109dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNd79be126-39cd-4dbb-ad88-0e4c18109dda7
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDd79be126-39cd-4dbb-ad88-0e4c18109dda7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-155-107120501551010 TABLET, FILM COATED in 1 BOTTLE (71205-155-10) 2024-05-14NoNoCurrent
71205-155-167120501551616 TABLET, FILM COATED in 1 BOTTLE (71205-155-16) 2023-02-20NoNoCurrent
71205-155-207120501552020 TABLET, FILM COATED in 1 BOTTLE (71205-155-20) 2018-11-010000-00-00NoNoCurrent
71205-155-307120501553030 TABLET, FILM COATED in 1 BOTTLE (71205-155-30) 2018-11-010000-00-00NoNoCurrent
71205-155-607120501556060 TABLET, FILM COATED in 1 BOTTLE (71205-155-60) 2018-11-010000-00-00NoNoCurrent
71205-155-907120501559090 TABLET, FILM COATED in 1 BOTTLE (71205-155-90) 2018-11-010000-00-00NoNoCurrent