Home NDC 17856-0507-1 Hydroxyzine Hydrochloride
Product NDC 17856-0507
Requested package NDC 17856-0507-1
11-digit product format 178560507
Labeler code 17856
Product ID 17856-0507_34f4870b-c857-c0d9-e063-6294a90a011a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA201674
Marketing category ANDA
Marketing start 2013-08-21
Substance HYDROXYZINE DIHYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0507 17856-0507-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A201674-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201674-001 AA
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 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201674-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2013-08-21 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 Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYZINE DIHYDROCHLORIDE 10 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995241 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 17856-0507-1 Hydroxyzine Hydrochloride 72 in 1 BOX, UNIT-DOSE SOLUTION 72 5 17856-0507-2 Hydroxyzine Hydrochloride 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0507 HYDROXYZINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 5 Current NDC, Legacy NDC, 2 package rows 20250514_a2fbc502-6ca3-4304-9069-b7249c9d9489.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17856-0507-1 17856050701 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2) 2024-05-08 0000-00-00 No No Current