FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
71205-273
Requested package NDC
71205-273-60
11-digit product format
712050273
Labeler code
71205
Product ID
71205-273_7160086d-21ca-4ca0-9aee-1680c2c4d61c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040602
Marketing category
ANDA
Marketing start
2015-03-31
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76755771U3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995258Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
daefb617-209a-428b-9567-adc5880fa65cAvailable on FDA.report

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
71205-273-15Hydroxyzine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
71205-273-20Hydroxyzine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
71205-273-30Hydroxyzine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71205-273-60Hydroxyzine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71205-273-90Hydroxyzine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-273-20EA - Each71205-273fd4a2328-ed0f-4c49-a674-ff32821988d012019-08-06
71205-273-30EA - Each71205-27366c41aff-da3c-44a1-adae-779df00d2a7f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-273HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20221110_daefb617-209a-428b-9567-adc5880fa65c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackd03fdfd0-5dbd-40fe-a6e3-082a47751c2c2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.79f38cc2-f72f-3f30-e053-2991aa0ac5402024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc59f24b5-0527-423a-ab14-db1ba1f7763f2024-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack1c7d31fb-5e3c-456e-be6c-a3baafe60c372024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsc2bce6a4-9feb-4816-a6d8-151e8ef3314d2024-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionse83de74d-b2e0-45c5-b072-170a96216d3a2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd618157e-f43f-4b31-ba5b-8a13a94885bc2023-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions49ee4ecf-b2c0-4301-89da-111e4d8531682023-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3d5d3ebf-e57e-4ed1-be97-d4b299fb738d2023-09-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEProficient Rx LPdaefb617-209a-428b-9567-adc5880fa65c2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040602
application number: ANDA040602
ndc (package): 71205-273-60
ndc (product): 71205-273
ndc11 (package): 71205027360

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSNdaefb617-209a-428b-9567-adc5880fa65c3
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDdaefb617-209a-428b-9567-adc5880fa65c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-273-607120502736060 TABLET, FILM COATED in 1 BOTTLE (71205-273-60) 2019-05-010000-00-00NoNoCurrent