Home NDC 76420-921 Hydroxyzine Pamoate
Product NDC 76420-921
11-digit product format 764200921
Labeler code 76420
Product ID 76420-921_2e63fa75-efcf-d9ee-e063-6394a90ab2d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Pamoate
Dosage form CAPSULE
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA088487
Marketing category ANDA
Marketing start 1984-07-01
Substance HYDROXYZINE PAMOATE
Active strength 50 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-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 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995232 Internal RxNorm lookup 995253 Internal RxNorm lookup 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 76420-921-01 Hydroxyzine Pamoate 100 in 1 BOTTLE CAPSULE 100 1 76420-921-05 Hydroxyzine Pamoate 500 in 1 BOTTLE CAPSULE 500 1 76420-921-30 Hydroxyzine Pamoate 30 in 1 BOTTLE CAPSULE 30 1 76420-921-60 Hydroxyzine Pamoate 60 in 1 BOTTLE CAPSULE 60 1 76420-921-90 Hydroxyzine Pamoate 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-921 HYDROXYZINE PAMOATE CAPSULE [ASCLEMED USA, INC.] 1 Current NDC, 5 package rows 20250223_82187031-779e-47bc-943c-eb1a1ef30a7a.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 76420-921-01 76420092101 100 CAPSULE in 1 BOTTLE (76420-921-01) 100 capsule 2025-02-18 No No Current 76420-921-05 76420092105 500 CAPSULE in 1 BOTTLE (76420-921-05) 500 capsule 2025-02-18 No No Current 76420-921-30 76420092130 30 CAPSULE in 1 BOTTLE (76420-921-30) 30 capsule 2025-02-18 No No Current 76420-921-60 76420092160 60 CAPSULE in 1 BOTTLE (76420-921-60) 60 capsule 2025-02-18 No No Current 76420-921-90 76420092190 90 CAPSULE in 1 BOTTLE (76420-921-90) 90 capsule 2025-02-18 No No Current