Hydroxyzine Hydrochloride
- Product NDC
- 70518-1832
- Requested package NDC
- 70518-1832-0
- 11-digit product format
- 705181832
- Labeler code
- 70518
- Product ID
- 70518-1832_c16d7678-2b75-79b3-e053-2995a90ad577
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040788
- Marketing category
- ANDA
- Marketing start
- 2019-01-30
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 70518-1832 | 70518-1832-0 | 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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 70518-1832-0 | 2023-03-06 | HYDROXYZINE HYDROCHLORIDE TABLETS, USP |
| 70518-1832-1 | 2023-03-06 | HYDROXYZINE HYDROCHLORIDE TABLETS, USP |
| 70518-1832-0 | 2023-01-30 | HYDROXYZINE HYDROCHLORIDE TABLETS, USP |
| 70518-1832-1 | 2023-01-30 | HYDROXYZINE HYDROCHLORIDE TABLETS, USP |
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 | PD-Rx Pharmaceuticals, Inc. | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 2025-10-17 | Warnings, Adverse reactions | 040788 ANDA040788 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 263d3f22-a105-4abb-8152-be2081eefcde | 2025-10-15 | Warnings, Adverse reactions | 040788 ANDA040788 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-1832-0 | 70518183200 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1832-0) | 2019-01-30 | 0000-00-00 | No | No | Current |