Home NDC 0440-1617 Hydroxyzine Hydrochloride
Product NDC 0440-1617
11-digit product format 004401617
Labeler code 0440
Product ID 0440-1617_5c7814c1-de25-4959-9ac2-6be8c8e5e9c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Liberty Pharmaceuticals, Inc.
Application ANDA040787
Marketing category ANDA
Marketing start 2012-07-24
Marketing end 0000-00-00
Substance HYDROXYZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0440-1617-12 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0440-1617-12 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0440-1617-12 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0440-1617-12 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0440-1617-12 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0440-1617-12 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0440-1617-12 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0440-1617-12 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0440-1617-12 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0440-1617-12 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0440-1617-12 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0440-1617-12 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0440-1617-12 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0440-1617-12 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0440-1617-12 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0440-1617-12 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0440-1617-12 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0440-1617-12 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0440-1617-12 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0440-1617-12 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0440-1617-12 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0440-1617-12 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0440-1617-12 Hydroxyzine Hydrochloride 12 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 12 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0440-1617 HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.] 1 Legacy NDC, 1 package rows 20130910_308252c8-08ef-4864-846b-fbcae823141f.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 Status 0440-1617-12 00440161712 12 in 1 BOTTLE, PLASTIC Historical