Home NDC 51655-252 Hydroxyzine Pamoate
Product NDC 51655-252
11-digit product format 516550252
Labeler code 51655
Product ID 51655-252_48e6bda3-48ba-5ce2-e063-6394a90a9e15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Pamoate
Dosage form CAPSULE
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA088487
Marketing category ANDA
Marketing start 2023-04-25
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088487-001 HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088487-001 AB
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088487-001 HYDROXYZINE PAMOATE EQ 50MG HYDROCHLORIDE CAPSULE / ORAL AB 1984-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydroxyzine Pamoate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE PAMOATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M20215MUFR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995278 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51655-252-52 Hydroxyzine Pamoate 30 in 1 BOTTLE, PLASTIC CAPSULE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-252 HYDROXYZINE PAMOATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] 1 Current NDC, 1 package rows 20230707_faf7932b-40ee-8822-e053-6394a90a5e40.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-252-52 51655025252 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-252-52) 30 capsule 2023-04-25 No No Current