Application 204279
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204279-001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204279-001 | AB |
| A204279-002 | AB |
| A204279-003 | AB |
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.
| 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 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204279-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 2fc9b08a-e675-dbc5-e063-6294a90ad054 | 2025-07-02 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2 | 2025-06-27 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 44c63e67-a9e0-4a4f-b34e-2ca60a981766 | 2025-06-20 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f9ff4b7c-dc81-47af-8371-5c681eb0d876 | 2025-05-16 | Warnings, Adverse reactions | 204279 ANDA204279 23155-500 23155-501 23155-502 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | b52e1759-8be3-4e46-a891-4eaa9270c421 | 2025-05-15 | Warnings, Adverse reactions | 204279 ANDA204279 50090-2818 50090-2648 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0c687cbe-ce40-4bc0-b880-5166b5be7a80 | 2025-03-20 | Warnings, Adverse reactions | 204279 ANDA204279 0615-8082 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 09092888-0c18-501d-e063-6294a90aad67 | 2024-12-31 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Asclemed USA, Inc. | 4f3266f4-00a6-4c0c-bff2-e606913de894 | 2024-12-17 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7b6ebf69-77d5-434f-81a4-3d5587fd431e | 2024-08-29 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 9714d429-e7f6-4adf-b3f0-cb21e6edb433 | 2024-08-15 | Warnings, Adverse reactions | 204279 ANDA204279 63629-1856 63629-4929 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a8af7dd0-fef8-5c39-e053-2a95a90ae11a | 2024-07-17 | Warnings, Adverse reactions | 204279 ANDA204279 68071-5286 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1bf88820-e5f9-06e7-e063-6294a90a80ad | 2024-06-28 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 2562692e-e9cc-4f81-bdc9-47b7d4233758 | 2024-04-05 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Medsource Pharmaceuticals | 13172e1e-2b62-8a67-e063-6394a90a3010 | 2024-03-07 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 80e60583-76d3-4e65-8581-4cdaff7cd1c1 | 2023-10-23 | Warnings, Adverse reactions | 204279 ANDA204279 50090-3583 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 2e346b0c-9407-4346-82c2-d9755cbcd8b0 | 2023-09-11 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 92d8cc57-7e3a-4217-9160-e1b56db5570e | 2023-05-09 | Warnings, Adverse reactions | 204279 ANDA204279 50090-5297 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 73993c7e-acd7-4835-be03-f8274a15955b | 2022-06-01 | Warnings, Adverse reactions | 204279 ANDA204279 63187-354 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 2da6dd2f-90e2-464a-ad2a-292575cb0428 | 2022-05-02 | Warnings, Adverse reactions | 204279 ANDA204279 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8037 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8082 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 23155-500 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-500 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-500 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-501 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-501 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-501 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-502 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-502 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-502 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 33261-161 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-779 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-779 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-779 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-779 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-779 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2648 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2648 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2648 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2648 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2818 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2818 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3583 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3583 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3583 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5297 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0501 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-076 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-080 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 51655-080 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 52959-481 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | H.J Harkins Company inc. | ANDA | Current |
| 53002-3901 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-225 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-236 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-829 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-829 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 60760-307 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | St. Mary | ANDA | Current |
| 60760-307 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | St. Mary | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 61919-217 | HYDROXYZINE HCL | HYDROXYZINE HCL | DIRECT RX | ANDA | Current |
| 63187-354 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-354 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-354 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-354 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-733 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-733 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-733 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-733 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-733 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-1856 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1856 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1856 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4929 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4929 | Hydroxyzine Hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4929 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66267-499 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-792 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-279 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-713 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1532 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1532 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1532 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-5286 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5286 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7854 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Preferred Pharmaceuticals Incl | ANDA | Current |
| 68788-7854 | Hydroxyzine hydrochloride | Hydroxyzine hydrochloride | Preferred Pharmaceuticals Incl | ANDA | Current |