FDA.reportPublic FDA data

Hydroxyzine hydrochloride

Product NDC
71205-541
11-digit product format
712050541
Labeler code
71205
Product ID
71205-541_db55bfa9-59e8-40d3-9bc3-4bdadb2eb389
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204279
Marketing category
ANDA
Marketing start
2014-08-20
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

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
71205-541-15Hydroxyzine hydrochloride15 in 1 BOTTLETABLET152
71205-541-20Hydroxyzine hydrochloride20 in 1 BOTTLETABLET202
71205-541-30Hydroxyzine hydrochloride30 in 1 BOTTLETABLET302
71205-541-60Hydroxyzine hydrochloride60 in 1 BOTTLETABLET602
71205-541-90Hydroxyzine hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-541-30EA - Each71205-5410b06c427-0a7a-4d23-bb78-c2d90b9f37a912021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-541HYDROXYZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20220512_2da6dd2f-90e2-464a-ad2a-292575cb0428.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN2da6dd2f-90e2-464a-ad2a-292575cb04282
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD2da6dd2f-90e2-464a-ad2a-292575cb04282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-541-157120505411515 TABLET in 1 BOTTLE (71205-541-15) 15 tablet2021-03-040000-00-00NoNoCurrent
71205-541-207120505412020 TABLET in 1 BOTTLE (71205-541-20) 20 tablet2021-03-040000-00-00NoNoCurrent
71205-541-307120505413030 TABLET in 1 BOTTLE (71205-541-30) 30 tablet2021-03-040000-00-00NoNoCurrent
71205-541-607120505416060 TABLET in 1 BOTTLE (71205-541-60) 60 tablet2021-03-040000-00-00NoNoCurrent
71205-541-907120505419090 TABLET in 1 BOTTLE (71205-541-90) 90 tablet2021-03-040000-00-00NoNoCurrent