Hydroxyzine Hydrochloride
- Product NDC
- 68071-4633
- 11-digit product format
- 680714633
- Labeler code
- 68071
- Product ID
- 68071-4633_bbf253ef-d989-3ce0-e053-2995a90a5a75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040600
- Marketing category
- ANDA
- Marketing start
- 2015-03-31
- 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
- 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 | 68071-4633 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded package | package | 68071-4633 | 68071-4633-3 | I | Inactivated by FDA | 2026-09-09 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-4633-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-4633-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-4633-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-4633-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-4633-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-4633-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-4633-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-4633-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-4633-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68071-4633-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68071-4633-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68071-4633-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4633-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4633-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4633-3 | 1332a3947898… | d4bfe170f9cd… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 57311cfb-679a-da1a-b70c-8757f7fc431a | Product name | 4 | 20250516 |
| aa1826f4-97c1-4705-bdf0-3bc7d234e618 | Product name | 2 | 20190618 |
| 75cb12ee-8eb2-4f1a-a332-5743a5d0da41 | Product name | 1 | 20151110 |
| 3ca5f78b-43dc-30fe-8014-55b922af52b3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4633-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1072-a910-e053-dadaa90a0b85 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
| 68071-4633-3 | 2021-02-22 | C162847 | 48780-1 | ba0f9c33-1072-a910-e053-dadaa90a0b85 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
| 68071-4633-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1072-a910-e053-dadaa90a0b85 | Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4633-3 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4633 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Legacy NDC, 1 package rows | 20210223_7b1ba394-d8b3-cb24-e053-2a91aa0ab772.zip |
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995218 | hydrOXYzine HCl 10 MG Oral Tablet | PSN | 7b1ba394-d8b3-cb24-e053-2a91aa0ab772 | 4 |
| 995218 | hydroxyzine hydrochloride 10 MG Oral Tablet | SCD | 7b1ba394-d8b3-cb24-e053-2a91aa0ab772 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-4633-3 | 68071463303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4633-3) | 2018-11-20 | 0000-00-00 | No | No | Current |