Application 040659
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
| 002 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040659-001 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | |
| A040659-002 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040659-001 | AA |
| A040659-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040659-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040659-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040659-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040659-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040659-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040659-002 | AA | 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 |
|---|---|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | REMEDYREPACK INC. | ba2fb6de-af86-4c05-9018-135e1f8594f9 | 2026-07-03 | Warnings, Adverse reactions | 040659 ANDA040659 70518-1308 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Northwind Health Company, LLC | c443873a-2e89-43b2-b145-dde3dadf7bc0 | 2026-01-19 | Warnings, Adverse reactions | 040659 ANDA040659 51655-107 |
| Meclizine Hydrocloride | MECLIZINE HYDROCLORIDE | QPharma Inc | aa0fb895-a867-4482-9bc2-16eee8bfaaa0 | 2025-12-04 | Warnings, Adverse reactions | 040659 ANDA040659 42708-102 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 522b55a2-313c-45e8-b1be-07746ada5b0a | 2025-10-31 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | Bryant Ranch Prepack | f43bf077-3f29-48ec-8ca8-eb294dbf2001 | 2025-09-16 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 6dd657ba-46dc-4106-9f6a-dfa0ecf85752 | 2025-09-11 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 6c66ee38-10bb-4559-9d2f-51e6d6f091ee | 2025-09-04 | Warnings, Adverse reactions | 040659 ANDA040659 63629-2432 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | Jubilant Cadista Pharmacuticals Inc. | 9350fefc-9c00-182c-c3a9-044d4a40856f | 2025-07-31 | Warnings, Adverse reactions | 040659 ANDA040659 59746-121 59746-122 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | NuCare Pharmaceuticals,Inc. | 64a508ae-768a-2fba-e053-2991aa0ac42d | 2024-07-17 | Warnings, Adverse reactions | 040659 ANDA040659 68071-3017 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Proficient Rx LP | 6a8cbc12-0725-4462-bb71-0b18cefc19e7 | 2023-01-01 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | Proficient Rx LP | f574e123-8db7-4e3d-a0ee-e4e1f04ff146 | 2022-06-01 | Warnings, Adverse reactions | 040659 ANDA040659 63187-996 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | Asclemed USA, Inc. | 5c70e61b-a1e6-4981-92e2-1050cee08baa | 2020-10-30 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 53f410fd-104c-42c1-9740-6f48ffbc974f | 2020-05-22 | Warnings, Adverse reactions | 040659 ANDA040659 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-081 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-718 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-901 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-901 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-901 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-901 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-914 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 42708-102 | Meclizine Hydrocloride | Meclizine Hydrocloride | QPharma Inc | ANDA | Current |
| 42708-102 | Meclizine Hydrocloride | Meclizine Hydrocloride | QPharma Inc | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-899 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49467-124 | NAUS-EASE | MECLIZINE HYDROCHLORIDE | Sunascen Therapeutics LLC | ANDA | Current |
| 50090-2893 | Meclizine Hydrocloride | Meclizine Hydrocloride | A-S Medication Solutions | ANDA | Current |
| 50090-2893 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | A-S Medication Solutions | ANDA | Current |
| 50090-4577 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | A-S Medication Solutions | ANDA | Current |
| 50090-5203 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-3986 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-107 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-107 | Meclizine Hydrochloride | Meclizine Hydrochloride | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52959-033 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-3510 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3510 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-1116 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | DOH CENTRAL PHARMACY | ANDA | Current |
| 59746-121 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | JUBILANT CADISTA PHARMACE | ANDA | Current |
| 59746-121 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 59746-121 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 59746-122 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | JUBILANT CADISTA PHARMACE | ANDA | Current |
| 59746-122 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 59746-122 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | JUBILANT CADISTA PHARMACEUTICALS INC. | ANDA | Current |
| 60760-087 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-087 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-087 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | Direct_Rx | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-146 | Meclizine Hydrochloride | Meclizine Hydrochloride | DIRECT RX | ANDA | Current |
| 61919-886 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-886 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63187-996 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Proficient Rx LP | ANDA | Current |
| 63187-996 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Proficient Rx LP | ANDA | Current |
| 63187-996 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Proficient Rx LP | ANDA | Current |
| 63187-996 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Proficient Rx LP | ANDA | Current |
| 63629-2432 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2432 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7965 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7965 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8092 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67296-1041 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1041 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1041 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | RedPharm Drug, Inc. | ANDA | Current |
| 68071-3017 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3017 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-3308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4488 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4694 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4694 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4694 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4694 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-0447 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1308 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-238 | MECLIZINE HYDROCHLORIDE | Meclizine Hydrocloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |