Active ingredient
Hydroxyzine
278 finished FDA listings contain Hydroxyzine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- HYDROXYZINE, HYDROXYZINE DIHYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE PAMOATE
- Dosage forms
- Capsule, Injection, Solution, Solution, Syrup, Tablet, Tablet, Film Coated
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 62
- Strengths listed
- 10 mg/1 · 10 mg/5ml · 100 mg/1 · 25 mg/1 · 25 mg/ml · 50 mg/1 · 50 mg/25ml · 50 mg/ml
- Brand names in FDA listings
- Hydroxyzine Hydrochloride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5553
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 087408 | AM REGENT | 1981-08-27 | 6 |
| ANDA 087479 | SANDOZ | 1981-12-14 | 22 |
| ANDA 086183 | SANDOZ | 1981-12-14 | 9 |
| ANDA 087294 | CHARTWELL RX | 1982-04-12 | 4 |
| ANDA 087871 | AUROBINDO PHARMA LTD | 1982-12-20 | 13 |
| ANDA 088488 | BARR LABS | 1984-06-15 | 4 |
| ANDA 088487 | BARR LABS | 1984-06-15 | 4 |
| ANDA 088496 | BARR | 1984-06-15 | 5 |
| ANDA 088617 | PLIVA | 1986-01-10 | 8 |
| ANDA 088618 | PLIVA | 1986-01-10 | 11 |
| ANDA 088619 | PLIVA | 1986-01-10 | 6 |
| ANDA 040156 | IMPAX LABS INC | 1996-07-15 | 14 |
| ANDA 040391 | PAI HOLDINGS PHARM | 2002-04-10 | 1 |
| ANDA 040604 | EPIC PHARMA LLC | 2004-12-28 | 11 |
| ANDA 040786 | KVK TECH | 2007-03-20 | 7 |
| ANDA 040840 | NORTHSTAR HLTHCARE | 2008-03-31 | 13 |
| ANDA 040805 | HETERO LABS LTD III | 2008-05-29 | 3 |
| ANDA 040804 | CHARTWELL RX | 2008-06-30 | 3 |
| ANDA 040808 | AMNEAL PHARM | 2008-09-24 | 3 |
| ANDA 201507 | HERITAGE PHARMA | 2013-06-03 | 24 |
| ANDA 201674 | LANNETT CO INC | 2013-08-21 | 3 |
| ANDA 204279 | HERITAGE | 2014-08-20 | 51 |
| ANDA 207121 | NUVO PHARMS INC | 2017-03-29 | 6 |
| ANDA 210634 | APOZEAL PHARMS | 2019-02-26 | 1 |
| ANDA 217652 | GRAVITI PHARMS | 2023-08-17 | 24 |
| ANDA 219289 | BIONPHARMA | 2025-04-28 | 2 |
| ANDA 219648 | NOVITIUM PHARMA | 2025-12-16 | 1 |
| ANDA 220271 | SCIEGEN PHARMS | 2026-06-11 | 1 |
Official labeling on DailyMed
- HYDROXYZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- HYDROXYZINE HYDROCHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-09-02
- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 7 · 2026-08-31
- HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.] · version 11 · 2026-08-07
- HYDROXYZINE HYDROCHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-08-06
- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 2 · 2026-07-31
- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-07-29
- HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] · version 8 · 2026-07-27
- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-07-24
- HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 17 · 2026-07-24
- HYDROXYZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] · version 22 · 2026-07-22
- HYDROXYZINE HYDROCHLORIDE SOLUTION [APOZEAL PHARMACEUTICALS INC] · version 10 · 2026-07-22
Showing the 12 most recent of 220 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.