Home NDC 60432-150-16 Hydroxyzine Hydrochloride
Product NDC 60432-150
Requested package NDC 60432-150-16
11-digit product format 604320150
Labeler code 60432
Product ID 60432-150_36313fd7-73e3-403a-8f21-1ff4a0159037
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyzine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA087294
Marketing category ANDA
Marketing start 1995-03-09
Marketing end 0000-00-00
Substance HYDROXYZINE HYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 A087294-001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087294-001 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 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 1982-04-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087294-001 HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RLD, RS 1982-04-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 60432-150-04 Hydroxyzine Hydrochloride 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 11 60432-150-16 Hydroxyzine Hydrochloride 473 mL in 1 BOTTLE, PLASTIC SYRUP 473 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydroxyzine Hydrochloride ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 Hydroxyzine ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 alcohol INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 peppermint oil INACTIVE INGREDIENT AV092KU4JH HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 spearmint oil INACTIVE INGREDIENT C3M81465G5 HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 6 HYDROXYZINE HYDROCHLORIDE ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 HYDROXYZINE ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SPEARMINT OIL INACTIVE INGREDIENT C3M81465G5 HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 Hydroxyzine Hydrochloride ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Hydroxyzine Hydrochloride ACTIVE INGREDIENT 76755771U3 HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Hydroxyzine ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Hydroxyzine ACTIVE MOIETY 30S50YM8OG HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 alcohol INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 alcohol INACTIVE INGREDIENT 3K9958V90M HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Peppermint oil INACTIVE INGREDIENT AV092KU4JH HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 peppermint oil INACTIVE INGREDIENT AV092KU4JH HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 spearmint oil INACTIVE INGREDIENT C3M81465G5 HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Spearmint oil INACTIVE INGREDIENT C3M81465G5 HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Sucrose INACTIVE INGREDIENT C151H8M554 HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP] 1 Water INACTIVE INGREDIENT 059QF0KO0R HYDROXYZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-150 HYDROXYZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.] 11 Legacy NDC, 2 package rows 20181214_117aeccc-1a78-46d8-ad8d-4035870ad910.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 Units Marketing start Marketing end Sample Exclude flag Status 60432-150-16 60432015016 473 mL in 1 BOTTLE, PLASTIC (60432-150-16) 473 ml 1995-03-09 0000-00-00 No No Current