Home NDC 70518-4170 HYDROXYZINE HYDROCHLORIDE
Product NDC 70518-4170
11-digit product format 705184170
Labeler code 70518
Product ID 70518-4170_5cde18eb-09c3-9f47-e063-6294a90a00fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydroxyzine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA217652
Marketing category ANDA
Marketing start 2024-08-28
Substance HYDROXYZINE HYDROCHLORIDE
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 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 A217652-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 A217652-002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 A217652-003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17
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 2 · 66 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 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB RS 2023-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-002 HYDROXYZINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217652-003 HYDROXYZINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217652-001 HYDROXYZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-08-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE HYDROCHLORIDE 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4170-0 HYDROXYZINE HYDROCHLORIDE 30 in 1 BLISTER PACK TABLET, FILM COATED 30 8 70518-4170-1 HYDROXYZINE HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 8 70518-4170-2 HYDROXYZINE HYDROCHLORIDE 30 in 1 BLISTER PACK TABLET, FILM COATED 30 8 70518-4170-3 HYDROXYZINE HYDROCHLORIDE 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 8 70518-4170-4 HYDROXYZINE HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 8 70518-4170-5 HYDROXYZINE HYDROCHLORIDE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4170 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] 4 Current NDC, 6 package rows 20250406_f6ad4729-b291-42c4-8483-99385d8043db.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 2 of 2 · 22 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 70518-4170-0 70518417000 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4170-0) 2024-08-28 No No Current 70518-4170-1 70518417001 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-1) 2025-04-04 No No Current 70518-4170-2 70518417002 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4170-2) 2025-07-08 No No Current 70518-4170-3 70518417003 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-3) 2025-10-24 No No Current 70518-4170-4 70518417004 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-4) 2025-12-22 No No Current 70518-4170-5 70518417005 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-5) 2026-04-09 No No Current 70518-4170-6 70518417006 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4170-6) 2026-10-02 No No Current