Application 087479

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 25MG HYDROCHLORIDENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A087479-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087479-001AB

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087479-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A087479-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A087479-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A087479-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087479-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087479-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A087479-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087479-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087479-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087479-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087479-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087479-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087479-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087479-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087479-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087479-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087479-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087479-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087479-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087479-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087479-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087479-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087479-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087479-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087479-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A087479-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087479-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087479-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087479-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A087479-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087479-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087479-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087479-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087479-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087479-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087479-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087479-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087479-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087479-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087479-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087479-001AB13a93d1ddd44b…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.561d8abe-97e8-5dc7-e063-6294a90a39232026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.6432d1aa-1e73-469e-835b-43d518963f712026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 70518-1504
hydroxyzine pamoateHYDROXYZINE PAMOATEREMEDYREPACK INC.2e59dc14-7e17-4663-bc1f-7ee8e104dbfa2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 70518-0209
hydroxyzine pamoateHYDROXYZINE PAMOATEUnit Dose Solutions, Inc.55012f2c-fa10-2a31-e063-6294a90ae7182026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATECoupler LLC545f0e87-2688-5381-e063-6394a90a72d42026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
Hydroxyzine PamoateHYDROXYZINE PAMOATEDirect_Rx8a7084e0-530c-607b-e053-2a95a90a229c2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 61919-880
hydroxyzine pamoateHYDROXYZINE PAMOATENorthwind Health Company, LLCf99da162-f224-1c19-e053-6294a90acffb2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPD-Rx Pharmaceuticals, Inc.53153595-41b9-4b2d-8b7d-0ffd29fdd1d82025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 43063-172
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack836ec7f1-e739-4b85-bb52-08d5c5ed4c112025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack2a869704-2ad0-4ef6-89e6-0f84c39542b62025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.54af47cd-65c2-4bc9-95cd-7883e56ed0352025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 68788-8119
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.aee7c4a8-10cb-2107-e053-2995a90a90e72025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 68071-2255
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack34f7e401-9b2c-7d63-e063-6394a90a1f002025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackf74e4b3e-992c-402d-92b8-258fccb42b642025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 71335-1714
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepack02616eee-a1a4-4afc-b84e-69fd287551382024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 63629-8874
hydroxyzine pamoateHYDROXYZINE PAMOATENuCare Pharmaceutcals, Inc.2879c79f-bf2f-0bc9-e063-6394a90a98ae2024-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEBryant Ranch Prepackfac2df9d-d395-4b07-b299-2ed946441b222024-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEPharmasource Meds, LLCf563aa1a-1e21-49d4-e053-2a95a90a32642024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCc29f005e-ae75-415d-9fd6-591f074dcda52023-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
hydroxyzine pamoateHYDROXYZINE PAMOATESandoz Incc38cfd32-2562-4d6c-8a2e-d9984c16d9eb2022-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087479
application number: ANDA087479
ndc (product): 0185-0674
ndc (product): 0185-0613

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0613Hydroxyzine PamoateHydroxyzine PamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0674hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0615-0331hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7860hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-172hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-172hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-172hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-172hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-406hydroxyzine pamoatehydroxyzine pamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0355hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-0355hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-0355hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-2812hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-2813hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
53002-6212hydroxyzine pamoatehydroxyzine pamoateRPK Pharmaceuticals, Inc.ANDACurrent
55154-2127Hydroxyzine PamoateHydroxyzine PamoateCardinal HealthANDACurrent
55154-2127Hydroxyzine PamoateHydroxyzine PamoateCardinal Health 107, LLCANDACurrent
55700-237hydroxyzine pamoatehydroxyzine pamoateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-237hydroxyzine pamoatehydroxyzine pamoateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-237hydroxyzine pamoatehydroxyzine pamoateLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0025hydroxyzine pamoatehydroxyzine pamoateClinical Solutions WholsesaleANDACurrent
58118-0025hydroxyzine pamoatehydroxyzine pamoateClinical Solutions WholsesaleANDACurrent
58118-0025hydroxyzine pamoatehydroxyzine pamoateClinical Solutions WholsesaleANDACurrent
58118-0025hydroxyzine pamoatehydroxyzine pamoateClinical Solutions WholsesaleANDACurrent
61919-880Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent
61919-880Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent
61919-880Hydroxyzine PamoateHydroxyzine PamoateDirect_RxANDACurrent
63629-6642hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-6642hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8874hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8874hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8874hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8877hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8877hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8877hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
67046-281Hydroxyzine PamoateHYDROXYZINE PAMOATEContract Pharmacy Services-PAANDACurrent
67296-1096hydroxyzine pamoatehydroxyzine pamoateRedPharm Drug, Inc.ANDACurrent
68071-2255hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2255hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2255hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68084-847Hydroxyzine PamoateHydroxyzine PamoateAmerican Health PackagingANDACurrent
68084-847Hydroxyzine PamoateHydroxyzine PamoateAmerican Health PackagingANDACurrent
68084-847Hydroxyzine PamoateHydroxyzine PamoateAmerican Health PackagingANDACurrent
68788-8119hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-8119hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-9129hydroxyzine pamoatehydroxyzine pamoatePreferred PharmaceuticalsANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-0209hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1504hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70934-962hydroxyzine pamoatehydroxyzine pamoateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-558hydroxyzine pamoatehydroxyzine pamoateProficient Rx LPANDACurrent
71335-1714hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1714hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent