Hydroxyzine Hydrochloride
- Product NDC
- 68788-7476
- Requested package NDC
- 68788-7476-3
- 11-digit product format
- 687887476
- Labeler code
- 68788
- Product ID
- 68788-7476_02569aeb-baf6-4ee0-b9dd-722822b9e498
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA040600
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- 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
- 2021-12-31
- 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 package | package | 68788-7476 | 68788-7476-3 | D | Discontinued by firm | 2026-10-15 |
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 | 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7476-3 | EA - Each | 68788-7476 | fd2f489f-1634-4c49-9302-277c59fede23 | 1 | 2020-04-20 |
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 | Preferred Pharmaceuticals Inc. | 413a39ce-98d6-40f5-9048-ad464e98de44 | 2026-05-11 | Warnings, Adverse reactions | 040600 ANDA040600 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | dd9e5dc5-720c-4de8-abae-6404c31f341f | 2025-03-31 | Warnings, Adverse reactions | 040600 ANDA040600 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 1c7d31fb-5e3c-456e-be6c-a3baafe60c37 | 2024-04-02 | Warnings, Adverse reactions | 040600 ANDA040600 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7476-3 | 68788747603 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7476-3) | 2020-03-02 | 0000-00-00 | No | No | Current |