Hydroxyzine Hydrochloride
- Product NDC
- 70518-1730
- 11-digit product format
- 705181730
- Labeler code
- 70518
- Product ID
- 70518-1730_5ccb0982-8e0b-16e5-e063-6294a90a8d2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyzine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040787
- Marketing category
- ANDA
- Marketing start
- 2018-12-13
- Substance
- HYDROXYZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 70518-1730 | 70518-1730-0 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 70518-1730 | 70518-1730-1 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 70518-1730 | 70518-1730-2 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 70518-1730 | 70518-1730-3 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 70518-1730 | 70518-1730-4 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1730-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1730-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1730-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1730-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 70518-1730-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1730-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1730-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1730-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1730-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 70518-1730-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1730-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 70518-1730-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1730-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 70518-1730-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1730-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 70518-1730-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1730-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 70518-1730-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 70518-1730-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 70518-1730-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 70518-1730-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 70518-1730-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 70518-1730-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 70518-1730-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydroxyzine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROXYZINE HYDROCHLORIDE | 25 mg/1 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-1730-0 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 14 | |
| 70518-1730-1 | Hydroxyzine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 14 | |
| 70518-1730-2 | Hydroxyzine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | 14 | |
| 70518-1730-3 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 14 | |
| 70518-1730-4 | Hydroxyzine Hydrochloride | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | 14 | |
| 70518-1730-5 | Hydroxyzine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 14 | |
| 70518-1730-6 | Hydroxyzine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 14 | |
| 70518-1730-7 | Hydroxyzine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1730 | HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 10 | Current NDC, Legacy NDC, 8 package rows | 20250227_aa9523e0-c95d-4213-b213-96170d855536.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 | PD-Rx Pharmaceuticals, Inc. | 1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1 | 2025-10-17 | Warnings, Adverse reactions | 040787 ANDA040787 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 24cb9c83-a7e4-4bae-997c-c3a87426f78c | 2025-10-15 | Warnings, Adverse reactions | 040787 ANDA040787 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995258 | hydrOXYzine HCl 25 MG Oral Tablet | PSN | aa9523e0-c95d-4213-b213-96170d855536 | 14 |
| 995258 | hydroxyzine hydrochloride 25 MG Oral Tablet | SCD | aa9523e0-c95d-4213-b213-96170d855536 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70518-1730-0 | 70518173000 | 30 in 1 BOTTLE, PLASTIC | Historical | |||
| 70518-1730-1 | 70518173001 | 30 in 1 BLISTER PACK | Historical | |||
| 70518-1730-2 | 70518173002 | 30 in 1 BLISTER PACK | Historical | |||
| 70518-1730-3 | 70518173003 | 30 in 1 BOTTLE, PLASTIC | Historical | |||
| 70518-1730-4 | 70518173004 | 15 in 1 BOTTLE, PLASTIC | Historical | |||
| 70518-1730-5 | 70518173005 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1730-5) | 2025-06-18 | No | No | Current |
| 70518-1730-6 | 70518173006 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1730-6) | 2025-06-18 | No | No | Current |
| 70518-1730-7 | 70518173007 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1730-7) | 2025-10-22 | No | No | Current |