FDA.reportPublic FDA data

Application 087871

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087871-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB1982-12-20
A087871-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB1982-12-20
A087871-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB1982-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A087871-001AB
A087871-002AB
A087871-003AB

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 22:54:322026-06A087871-001HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB1982-12-20a50c72e98297…
2026-08-01 22:54:322026-06A087871-002HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB1982-12-20a50c72e98297…
2026-08-01 22:54:322026-06A087871-003HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB1982-12-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A087871-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A087871-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A087871-003AB1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackf84e3365-57d2-4904-9275-96600f8d74c72026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAurobindo Pharma Limited9de2de56-614f-4294-8794-d30758cf5f702026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
ndc (product): 59651-500
ndc (product): 59651-501
ndc (product): 59651-499
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack56b49e5c-bb8a-46cd-873c-3c743d1653a42026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3526a66b-2182-4b5a-a7d1-563d75f5335f2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack9504897e-febc-4293-a2dc-9f79f55ea8212025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepackeef36dab-c318-44d2-8583-7bae3bfceee72025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAmerican Health Packagingfc148d96-b868-4e45-b7d2-977faf4310492025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepacke4e6a91d-f10b-4d85-a526-4c6192ea85dc2025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepacka8c83479-f919-49f9-b125-747bd0e3211c2025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack7c959515-a5a9-4d5e-90e9-bd58bc9473302025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC138ec5c1-bb06-2a82-e063-6394a90ab42b2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087871
application number: ANDA087871

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-499Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-500Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-501Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAurobindo Pharma LimitedANDACurrent