Hydroxyzine Hydrochloride
- Product NDC
- 68071-4763
- 11-digit product format
- 680714763
- Labeler code
- 68071
- Product ID
- 68071-4763_bb8db612-ee0b-0a3a-e053-2995a90a79cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmceuticals,Inc.
- Application
- ANDA040602
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 25 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 product | product | 68071-4763 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 68071-4763 | 68071-4763-4 | D | Discontinued by firm | 2026-10-05 |
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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | 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 | 68071-4763-4 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68071-4763-4 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4763-4 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4763-4 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4763-4 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-08-20 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
| 2023-01-30 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
| 2021-02-17 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
| 2021-01-29 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
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 | Bryant Ranch Prepack | d03fdfd0-5dbd-40fe-a6e3-082a47751c2c | 2025-03-31 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 79f38cc2-f72f-3f30-e053-2991aa0ac540 | 2024-09-25 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | c59f24b5-0527-423a-ab14-db1ba1f7763f | 2024-04-16 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 1c7d31fb-5e3c-456e-be6c-a3baafe60c37 | 2024-04-02 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | c2bce6a4-9feb-4816-a6d8-151e8ef3314d | 2024-03-11 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | e83de74d-b2e0-45c5-b072-170a96216d3a | 2024-01-04 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d618157e-f43f-4b31-ba5b-8a13a94885bc | 2023-09-18 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 49ee4ecf-b2c0-4301-89da-111e4d853168 | 2023-09-11 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 3d5d3ebf-e57e-4ed1-be97-d4b299fb738d | 2023-09-07 | Warnings, Adverse reactions | 040602 ANDA040602 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | daefb617-209a-428b-9567-adc5880fa65c | 2022-11-01 | Warnings, Adverse reactions | 040602 ANDA040602 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-4763-4 | 68071476304 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-4763-4) | 2019-02-12 | 0000-00-00 | No | No | Current |