Home NDC 70518-2769 Hydroxyzine Pamoate
Product NDC 70518-2769
11-digit product format 705182769
Labeler code 70518
Product ID 70518-2769_4a8f5c13-54fe-3555-e063-6394a90ad9fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Pamoate
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA088488
Marketing category ANDA
Marketing start 2020-06-08
Substance HYDROXYZINE PAMOATE
Active strength 100 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 A088488-001 HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15
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 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088488-001 HYDROXYZINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE / ORAL 1984-06-15 cb3db0bc1861…
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 100 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 995232 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-2769-0 Hydroxyzine Pamoate 30 in 1 BLISTER PACK CAPSULE 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2769 HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250402_a21df116-501f-4818-ad10-ccfa7b03d7ad.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 Marketing end Sample Exclude flag Status 70518-2769-0 70518276900 30 CAPSULE in 1 BLISTER PACK (70518-2769-0) 30 capsule 2020-06-08 0000-00-00 No No Current