Hydroxyzine Pamoate

Product NDC
50268-399
11-digit product format
502680399
Labeler code
50268
Product ID
50268-399_47e54668-1645-b614-e063-6294a90ad949
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Pamoate
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA040156
Marketing category
ANDA
Marketing start
2021-04-14
Substance
HYDROXYZINE PAMOATE
Active strength
50 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 · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040156-001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15
A040156-002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040156-001AB
A040156-002AB

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040156-001HYDROXYZINE PAMOATEEQ 25MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A040156-002HYDROXYZINE PAMOATEEQ 50MG HYDROCHLORIDECAPSULE / ORALAB1996-07-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040156-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040156-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040156-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040156-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040156-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040156-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040156-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040156-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040156-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040156-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040156-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040156-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040156-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040156-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040156-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040156-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040156-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040156-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040156-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040156-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040156-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040156-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040156-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040156-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040156-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040156-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040156-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040156-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040156-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040156-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040156-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040156-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040156-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040156-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040156-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040156-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040156-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040156-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040156-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040156-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE PAMOATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M20215MUFRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995253Internal RxNorm lookup
995278Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bff08c15-89b1-00f7-e053-2995a90a2ad8Available 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
50268-399-11Hydroxyzine Pamoate1 in 1 BLISTER PACKCAPSULE15
50268-399-50Hydroxyzine Pamoate50 in 1 BOXCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-399-11EA - Each50268-399090faacd-0eb8-453d-bfc0-236068b5d5af12021-05-05
50268-399-50EA - Each50268-39957d39fca-7b83-4340-ac96-34b9a9f5e96112021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-399HYDROXYZINE PAMOATE CAPSULE [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_bff08c15-89b1-00f7-e053-2995a90a2ad8.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine PamoateHYDROXYZINE PAMOATEAmneal Pharmaceuticals of New York LLCbc82aaaf-30c7-4afe-a908-d138ea1268ef2026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEAvPAKbff08c15-89b1-00f7-e053-2995a90a2ad82026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
ndc (product): 50268-399
HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDirectRxd60603e7-15c5-7b01-e053-2995a90ad2522025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.8a8416f8-18ce-99e6-e053-2995a90a10452024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepack4ea3336a-2cc8-4e43-bc55-455fca67976e2023-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEA-S Medication Solutions42186eab-89d1-4963-bfd8-087b3024af332023-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEBryant Ranch Prepackf24c19d4-fd3e-4ed3-aeb7-7bc5e0dd02442023-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP04657694-e8a8-4e52-a179-cfe7528197602022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEProficient Rx LP23561142-45e0-46f5-b17f-d67760b4db272022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATENCS HealthCare of KY, LLC dba Vangard Labs207d3478-ac7f-485c-b8ca-e9fcebbdcd892022-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156
Hydroxyzine PamoateHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCd6a1df2e-c111-4ee7-9d56-469db19b7c602021-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040156
application number: ANDA040156

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995253hydrOXYzine pamoate 25 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydrOXYzine pamoate 50 MG Oral CapsulePSNbff08c15-89b1-00f7-e053-2995a90a2ad85
995253hydroxyzine pamoate 25 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG Oral CapsuleSCDbff08c15-89b1-00f7-e053-2995a90a2ad85
995278hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral CapsuleSYbff08c15-89b1-00f7-e053-2995a90a2ad85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-399-11502680399111 in 1 BLISTER PACKHistorical
50268-399-505026803995050 BLISTER PACK in 1 BOX (50268-399-50) / 1 CAPSULE in 1 BLISTER PACK (50268-399-11) 50 blister pack2021-04-140000-00-00NoNoCurrent