Hydroxyzine Hydrochloride
- Product NDC
- 68788-9307
- 11-digit product format
- 687889307
- Labeler code
- 68788
- Product ID
- 68788-9307_ac9f7fdb-e74f-4b29-ba45-f1db25630262
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA040804
- Marketing category
- ANDA
- Marketing start
- 2015-04-15
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-9307 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 68788-9307 | 68788-9307-3 | D | Discontinued by firm | 2026-08-10 |
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.
| 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 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-9307-3 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 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 | 68788-9307-3 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040804-001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | |
| A040804-002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | |
| A040804-003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040804-001 | AB |
| A040804-002 | AB |
| A040804-003 | 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 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2008-06-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2008-06-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040804-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-06-30 | 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 | A040804-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040804-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040804-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040804-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040804-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040804-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040804-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040804-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040804-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040804-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040804-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040804-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040804-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040804-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040804-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040804-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-9307-3 | 2020-11-11 | C162847 | 48780-1 | 9d75b9d0-8ef9-f424-e053-dadaa90a57ce | HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only |
| 68788-9307-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8ef9-f424-e053-dadaa90a57ce | HYDROXYZINE HYDROCHLORIDE TABLETS, USP Rx only |
DailyMed Socrata Ingredients#
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 | Chartwell RX, LLC | 934afb42-fee8-415b-8090-2265bb299afe | 2024-10-28 | Warnings, Adverse reactions | 040804 ANDA040804 |