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PAMOATE | CAPSULE;ORAL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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 | RLD, Approved before 1982 | ||
| N011459-004 | VISTARIL | HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | 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| HYDROXYZINE PAMOATE | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 |
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 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011459-006 | VISTARIL | EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011459-002 | VISTARIL | EQ 25MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011459-004 | VISTARIL | EQ 50MG HYDROCHLORIDE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | ||
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N011459-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011459-004 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | Proficient Rx LP | b7f806ed-da18-41f2-aa0b-bce2336f2756 | 2022-11-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | 04657694-e8a8-4e52-a179-cfe752819760 | 2022-11-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | 23561142-45e0-46f5-b17f-d67760b4db27 | 2022-11-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Teva Pharmaceuticals USA, Inc. | 06068fff-2e79-4721-bcc7-b0938aa20e7a | 2022-10-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Sandoz Inc | c38cfd32-2562-4d6c-8a2e-d9984c16d9eb | 2022-06-27 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | b098e287-e489-4cdc-9171-7daf50380c1c | 2022-06-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | NCS HealthCare of KY, LLC dba Vangard Labs | 207d3478-ac7f-485c-b8ca-e9fcebbdcd89 | 2022-02-10 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| Hydroxyzine Pamoate | HYDROXYZINE PAMOATE | Aphena Pharma Solutions - Tennessee, LLC | d6a1df2e-c111-4ee7-9d56-469db19b7c60 | 2021-10-15 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
| hydroxyzine pamoate | HYDROXYZINE PAMOATE | Proficient Rx LP | bff75226-d194-4d64-bcbb-d7d79f5d230e | 2021-05-01 | Warnings, Adverse reactions | HYDROXYZINE PAMOATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |