Application 011459
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 25MG HYDROCHLORIDE | Yes | No |
| 004 | VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 50MG HYDROCHLORIDE | Yes | No |
| 006 | VISTARIL | HYDROXYZINE PAMOATE | CAPSULE;ORAL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011459-002 | VISTARIL | HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N011459-004 | VISTARIL | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N011459-006 | VISTARIL | HYDROXYZINE PAMOATE | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011459-002 | AB |
| N011459-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N011459-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011459-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011459-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011459-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011459-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N011459-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011459-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011459-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011459-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011459-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011459-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011459-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011459-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011459-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011459-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011459-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011459-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011459-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011459-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N011459-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011459-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011459-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011459-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011459-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011459-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011459-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011459-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N011459-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011459-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011459-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N011459-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N011459-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N011459-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N011459-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N011459-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N011459-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N011459-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N011459-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N011459-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N011459-004 | AB | 1 | 782e0a99824c… |
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 pamoate | HYDROXYZINE PAMOATE | Unit Dose Solutions, Inc. | 561d8abe-97e8-5dc7-e063-6294a90a3923 | 2026-07-08 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | REMEDYREPACK INC. | 6432d1aa-1e73-469e-835b-43d518963f71 | 2026-07-07 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | REMEDYREPACK INC. | 2e59dc14-7e17-4663-bc1f-7ee8e104dbfa | 2026-06-24 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Unit Dose Solutions, Inc. | 55012f2c-fa10-2a31-e063-6294a90ae718 | 2026-06-24 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine pamoate | HYDROXYZINE PAMOATE | Unit Dose Solutions, Inc. | 55033469-f5c6-5180-e063-6394a90af5eb | 2026-06-24 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine pamoate | HYDROXYZINE PAMOATE | Unit Dose Solutions, Inc. | 5505ef8f-0322-b705-e063-6394a90a5c5c | 2026-06-24 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Coupler LLC | 545f0e87-2688-5381-e063-6394a90a72d4 | 2026-06-16 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Amneal Pharmaceuticals of New York LLC | bc82aaaf-30c7-4afe-a908-d138ea1268ef | 2026-06-11 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Cardinal Health 107, LLC | 6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e | 2026-05-18 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine pamoate | HYDROXYZINE PAMOATE | Coupler LLC | 509e9a9c-23a3-ade4-e063-6294a90a7403 | 2026-04-29 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Coupler LLC | 5020c699-6fc5-b166-e063-6294a90a5881 | 2026-04-23 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine pamoate | HYDROXYZINE PAMOATE | REMEDYREPACK INC. | 0c9101ee-0746-4833-83cf-d0d09e52c0a9 | 2026-03-30 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | PD-Rx Pharmaceuticals, Inc. | 98a1c161-5728-4626-a6b0-5414935e4eef | 2026-03-18 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Direct_Rx | 8a7084e0-530c-607b-e053-2a95a90a229c | 2026-03-05 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | REMEDYREPACK INC. | a21df116-501f-4818-ad10-ccfa7b03d7ad | 2026-02-11 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Preferred Pharmaceuticals Inc. | b903f7e1-250d-46d8-a1ec-3f1dabc597f1 | 2026-01-23 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | AvPAK | bff08c15-89b1-00f7-e053-2995a90a2ad8 | 2026-01-08 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Northwind Health Company, LLC | 127617c2-9775-3859-e063-6394a90a77cd | 2026-01-05 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Northwind Health Company, LLC | faf7932b-40ee-8822-e053-6394a90a5e40 | 2026-01-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Northwind Health Company, LLC | f99da162-f224-1c19-e053-6294a90acffb | 2026-01-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-5410 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5410 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5410 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5410 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5420 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5420 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5420 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-5420 | Vistaril | hydroxyzine pamoate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-5420 | Hydroxyzine pamoate | hydroxyzine pamoate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5420 | Hydroxyzine pamoate | hydroxyzine pamoate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 70518-0500 | Vistaril | hydroxyzine pamoate | REMEDYREPACK INC. | NDA | Current |
| 70518-0500 | Vistaril | hydroxyzine pamoate | REMEDYREPACK INC. | NDA | Current |
| 70518-0500 | Vistaril | hydroxyzine pamoate | REMEDYREPACK INC. | NDA | Current |
| 70518-0500 | Vistaril | hydroxyzine pamoate | REMEDYREPACK INC. | NDA | Current |
| 70518-0500 | Vistaril | hydroxyzine pamoate | REMEDYREPACK INC. | NDA | Current |
| 70518-3323 | Hydroxyzine pamoate | hydroxyzine pamoate | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |