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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204279-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204279-001 | AB | 1 | 8072bd15b7f6… |
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 | Major Pharmaceuticals | 7f76580c-96a0-4b56-8986-ff5488bb9869 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | bb4a7d22-2f42-4e9f-bf98-cee43ed14d50 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc | c8b441bf-a03e-47b3-8f06-c347f5ca4b70 | 2026-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | b6189074-e199-4f58-a78d-c04f131c13d9 | 2026-07-10 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 83e8d60d-36fd-4223-b50c-e6615045352a | 2026-07-01 | Warnings, Adverse reactions | 204279 ANDA204279 63187-733 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5506e802-0efc-a845-e063-6394a90aad0e | 2026-06-24 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Incl | 63fdf791-1a58-45ba-8ef2-15b80bb24f23 | 2026-05-11 | Warnings, Adverse reactions | 204279 ANDA204279 68788-7854 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Coupler LLC | 508848a5-017c-dd3e-e063-6294a90a456b | 2026-04-28 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4cd84205-6a33-db48-e063-6394a90a9182 | 2026-04-16 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 71eea118-395c-4559-aed5-900b635674b8 | 2026-02-12 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 1350964e-663e-4a50-8c4c-cda371a694a0 | 2026-02-04 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | 4c2c4d8e-c3d1-48c7-8f99-ffa159667465 | 2026-01-19 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | f2b3d10f-2599-5b71-e053-2a95a90a54bb | 2026-01-01 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c134195e-a048-530a-e053-2a95a90ad9f8 | 2025-12-26 | Warnings, Adverse reactions | 204279 ANDA204279 51655-076 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Northwind Health Company, LLC | c13455a3-3078-4fe1-e053-2a95a90adf8e | 2025-12-26 | Warnings, Adverse reactions | 204279 ANDA204279 51655-080 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Chartwell RX, LLC | 6533bb4f-efbc-4fca-b625-daa1b3978740 | 2025-12-10 | Warnings, Adverse reactions | 204279 ANDA204279 |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Direct Rx | d956063a-ef48-faca-e053-2995a90a0291 | 2025-10-06 | 204279 ANDA204279 | |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ca015a35-1f94-4f92-9143-3f149982d316 | 2025-07-15 | Warnings, Adverse reactions | 204279 ANDA204279 43063-779 |
| 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 |
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 |