Hydroxyzine hydrochloride
- Product NDC
- 70518-0488
- 11-digit product format
- 705180488
- Labeler code
- 70518
- Product ID
- 70518-0488_e1aa727c-7390-86d1-e053-2995a90a3d52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204279
- Marketing category
- ANDA
- Marketing start
- 2017-05-08
- Marketing end
- 0000-00-00
- Substance
- HYDROXYZINE DIHYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 70518-0488 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-0488 | 70518-0488-0 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 70518-0488 | 70518-0488-1 | 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0488-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0488-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0488-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0488-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0488-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0488-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0488-1 | 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 | 70518-0488-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0488-1 | 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 | 70518-0488-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0488-1 | 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 | 70518-0488-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0488-1 | 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 | 70518-0488-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0488-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0488-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204279-001 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-002 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | |
| A204279-003 | HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204279-001 | AB |
| A204279-002 | AB |
| A204279-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | HYDROXYZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | HYDROXYZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2014-08-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | HYDROXYZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-20 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204279-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204279-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204279-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204279-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204279-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204279-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204279-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204279-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204279-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204279-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204279-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204279-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204279-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204279-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204279-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-0488 | HYDROXYZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 16 | Legacy NDC | 20250427_a38aa72a-9e39-4d52-895c-a5be49241a6b.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 | Golden State Medical Supply, Inc. | 2fc9b08a-e675-dbc5-e063-6294a90ad054 | 2025-07-02 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | e4c60e14-28c7-46e2-9fdc-b1a1ce54f3c2 | 2025-06-27 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 44c63e67-a9e0-4a4f-b34e-2ca60a981766 | 2025-06-20 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | f9ff4b7c-dc81-47af-8371-5c681eb0d876 | 2025-05-16 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | b52e1759-8be3-4e46-a891-4eaa9270c421 | 2025-05-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 0c687cbe-ce40-4bc0-b880-5166b5be7a80 | 2025-03-20 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 09092888-0c18-501d-e063-6294a90aad67 | 2024-12-31 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Asclemed USA, Inc. | 4f3266f4-00a6-4c0c-bff2-e606913de894 | 2024-12-17 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7b6ebf69-77d5-434f-81a4-3d5587fd431e | 2024-08-29 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 9714d429-e7f6-4adf-b3f0-cb21e6edb433 | 2024-08-15 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a8af7dd0-fef8-5c39-e053-2a95a90ae11a | 2024-07-17 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1bf88820-e5f9-06e7-e063-6294a90a80ad | 2024-06-28 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Bryant Ranch Prepack | 2562692e-e9cc-4f81-bdc9-47b7d4233758 | 2024-04-05 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Medsource Pharmaceuticals | 13172e1e-2b62-8a67-e063-6394a90a3010 | 2024-03-07 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 80e60583-76d3-4e65-8581-4cdaff7cd1c1 | 2023-10-23 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 2e346b0c-9407-4346-82c2-d9755cbcd8b0 | 2023-09-11 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 92d8cc57-7e3a-4217-9160-e1b56db5570e | 2023-05-09 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 73993c7e-acd7-4835-be03-f8274a15955b | 2022-06-01 | Warnings, Adverse reactions | 204279 ANDA204279 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Proficient Rx LP | 2da6dd2f-90e2-464a-ad2a-292575cb0428 | 2022-05-02 | Warnings, Adverse reactions | 204279 ANDA204279 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-0488-0 | 70518048800 | 30 TABLET in 1 BLISTER PACK (70518-0488-0) | 30 tablet | 2017-05-08 | 0000-00-00 | No | No | Current |
| 70518-0488-1 | 70518048801 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-0488-1) | 30 tablet | 2017-10-06 | 0000-00-00 | No | No | Current |