FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
60760-285
Requested package NDC
60760-285-20
11-digit product format
607600285
Labeler code
60760
Product ID
60760-285_4537cfd9-9816-831c-e063-6394a90a86f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA088617
Marketing category
ANDA
Marketing start
2020-02-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088617-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALABRLD, RS1986-01-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A088617-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A088617-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALABRLD, RS1986-01-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088617-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt Mary's Medical Park Pharmacy9ef6a4b7-362d-61b4-e053-2995a90a0ebb2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
ndc (package): 60760-285-20
ndc (product): 60760-285
ndc11 (package): 60760028520
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packaging47bda4fe-ddb7-4140-900a-970373cc7acc2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7165a30c-09e4-4ca1-8548-bf71998ba12f2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack93d117dd-e2bf-4daa-abe3-d4fefed3313c2025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9c2c05e0-b123-4ddf-8b07-6bb3ca0678b52025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.80309ec1-e5d5-4454-b8ce-67d7e6805e442025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.714a26a1-371f-ef23-e053-2a95a90a6af62024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions3946db7c-dc2d-4329-b9ac-f003d8c6d3e12024-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088617
application number: ANDA088617

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE HYDROCHLORIDE10 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ef6a4b7-362d-61b4-e053-2995a90a0ebbAvailable 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
60760-285-20Hydroxyzine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-285-20EA - Each60760-28538e468cd-07ae-4c37-8773-9421db7c6d6212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-285HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 1 package rows20230107_9ef6a4b7-362d-61b4-e053-2995a90a0ebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN9ef6a4b7-362d-61b4-e053-2995a90a0ebb3
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD9ef6a4b7-362d-61b4-e053-2995a90a0ebb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-285-206076002852020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-285-20) 2020-02-190000-00-00NoNoCurrent