Home NDC 10135-811 HYDROXYZINE HYDROCHLORIDE
Product NDC 10135-811
11-digit product format 101350811
Labeler code 10135
Product ID 10135-811_31a907fc-2be0-1219-e063-6294a90ac00f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydroxyzine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA207121
Marketing category ANDA
Marketing start 2025-03-01
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 25 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207121-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 A207121-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 A207121-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 121 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 2026-09-14 22:38:34 2026-08 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207121-002 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207121-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2017-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207121-001 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2017-03-29 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 121 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base HYDROXYZINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE DIHYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76755771U3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995218 Internal RxNorm lookup 995258 Internal RxNorm lookup 995281 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 10135-811-01 HYDROXYZINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 1 10135-811-10 HYDROXYZINE HYDROCHLORIDE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-811 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20250403_31a907e6-7fae-0682-e063-6294a90a24a5.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 10135-811-01 10135081101 100 TABLET, FILM COATED in 1 BOTTLE (10135-811-01) 2025-03-01 No No Current 10135-811-10 10135081110 1000 TABLET, FILM COATED in 1 BOTTLE (10135-811-10) 2025-03-01 No No Current