Application 010721
- Type
- NDA
- Sponsor
- CASPER PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANTIVERT | MECLIZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | Yes | No |
| 004 | ANTIVERT | MECLIZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | Yes | No |
| 005 | ANTIVERT | MECLIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 25MG | Yes | No |
| 006 | ANTIVERT | MECLIZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N010721-001 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 |
| N010721-004 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | |
| N010721-005 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | ||
| N010721-006 | ANTIVERT | MECLIZINE HYDROCHLORIDE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N010721-001 | AA |
| N010721-004 | AA |
| N010721-006 | 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| 2026-07 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-001 | ANTIVERT | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, RS | 1982-01-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-004 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-005 | ANTIVERT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-006 | ANTIVERT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | AA | RLD, Approved before 1982 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N010721-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N010721-004 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N010721-006 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-004 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N010721-006 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-004 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N010721-006 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-004 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N010721-006 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-004 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N010721-006 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-004 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N010721-006 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-004 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N010721-006 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-004 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N010721-006 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N010721-006 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-004 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N010721-006 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N010721-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N010721-004 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N010721-006 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010721-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010721-004 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N010721-006 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010721-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010721-004 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N010721-006 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N010721-001 | AA | 1 | 1e350fbaab3a… |
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 HYDROCHLORIDE | Coupler LLC | 598eb392-1dfe-c08c-e063-6394a90a4c7d | 2026-08-21 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | REMEDYREPACK INC. | 21d4a6ee-0a66-45d7-bab9-c5eef399713d | 2026-08-17 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | c6b3f4d8-5fcf-2278-e053-2a95a90ab139 | 2026-06-21 | Warnings, Adverse reactions | 010721 NDA010721 60760-661 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d7d31433-8f39-4fe6-b542-1b4410122db7 | 2026-06-12 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 81e1762b-e012-4c6d-96e6-9a9f27a1880a | 2026-05-27 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | REMEDYREPACK INC. | d53bf04e-5cfc-4974-9b24-2cce545d1bd0 | 2026-04-15 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | c31846b2-d47d-a97b-e053-2a95a90a9bec | 2026-03-27 | Warnings, Adverse reactions | 010721 NDA010721 68071-2416 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | beb36d86-9fb7-1f60-e053-2995a90aac13 | 2026-03-02 | Warnings, Adverse reactions | 010721 NDA010721 68071-2380 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 112103bc-25e2-42cf-8542-ba1d3392a2c3 | 2025-08-20 | Warnings, Adverse reactions | 010721 NDA010721 71335-1872 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | 27b6a7e0-a361-4705-9f31-719063a65f22 | 2025-08-20 | Warnings, Adverse reactions | 010721 NDA010721 71335-1825 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd | 2025-06-02 | Warnings, Adverse reactions | 010721 NDA010721 16571-662 16571-663 16571-661 16571-660 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 2d31ae73-3f09-a77c-e063-6294a90ade9a | 2025-02-02 | Warnings, Adverse reactions | 010721 NDA010721 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DirectRx | d27fe828-4fee-3ba9-e053-2995a90ae7b6 | 2025-01-20 | Warnings, Adverse reactions | 010721 NDA010721 72189-302 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Proficient Rx LP | 92e8390b-5173-4aa1-906d-35d2c0eaaaf6 | 2024-08-01 | Warnings, Adverse reactions | 010721 NDA010721 71205-647 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Direct_Rx | e79ecf77-0e0a-d7ef-e053-2a95a90a5adf | 2024-04-09 | Warnings, Adverse reactions | 010721 NDA010721 72189-237 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Asclemed USA, Inc. | e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db | 2024-04-08 | Warnings, Adverse reactions | 010721 NDA010721 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Proficient Rx LP | b91435d1-fb95-4939-8478-84e41f44f732 | 2023-04-01 | Warnings, Adverse reactions | 010721 NDA010721 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-660 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-660 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-662 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-662 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-663 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 16571-663 | Meclizine Hydrochloride | Meclizine Hydrochloride | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55700-912 | Meclizine Hydrochloride | Meclizine Hydrochloride | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 55700-919 | Meclizine Hydrochloride | Meclizine Hydrochloride | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 55700-919 | Meclizine Hydrochloride | Meclizine Hydrochloride | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 60760-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 60760-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 60760-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 60760-661 | Meclizine Hydrochloride | Meclizine Hydrochloride | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 67296-1432 | Meclizine Hydrochloride | Meclizine Hydrochloride | RedPharm Drug, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-2380 | Meclizine Hydrochloride | Meclizine Hydrochloride | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68071-2416 | Meclizine Hydrochloride | Meclizine Hydrochloride | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 70199-002 | Antivert | meclizine HCl | Casper Pharma LLC | NDA | Current |
| 70199-002 | Antivert | meclizine HCl | Casper Pharma LLC | NDA | Current |
| 70199-003 | Antivert | meclizine HCl | Casper Pharma LLC | NDA | Current |
| 70199-003 | Antivert | meclizine HCl | Casper Pharma LLC | NDA | Current |
| 70199-004 | Antivert | meclizine hcl | Casper Pharma LLC | NDA | Current |
| 70199-004 | Antivert | meclizine hcl | Casper Pharma LLC | NDA | Current |
| 70199-018 | Antivert | meclizine hcl | Casper Pharma LLC | NDA | Current |
| 70199-018 | Antivert | meclizine hcl | Casper Pharma LLC | NDA | Current |
| 71205-647 | Meclizine Hydrochloride | Meclizine Hydrochloride | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 71335-1825 | Meclizine Hydrochloride | Meclizine Hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-1872 | Meclizine Hydrochloride | Meclizine Hydrochloride | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 72189-237 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DIRECT RX | NDA AUTHORIZED GENERIC | Current |
| 72189-237 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DIRECT RX | NDA AUTHORIZED GENERIC | Current |
| 72189-237 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DIRECT RX | NDA AUTHORIZED GENERIC | Current |
| 72189-237 | Meclizine Hydrochloride | Meclizine Hydrochloride | Direct_Rx | NDA AUTHORIZED GENERIC | Current |
| 72189-302 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DirectRx | NDA AUTHORIZED GENERIC | Current |
| 72189-302 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | DirectRx | NDA AUTHORIZED GENERIC | Current |
| 74074-003 | Meclizine Hydrochloride | Meclizine Hydrochloride | Nortic Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 74074-003 | Meclizine Hydrochloride | Meclizine Hydrochloride | Nortic Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 74074-004 | Meclizine Hydrochloride | Meclizine Hydrochloride | Nortic Pharma, LLC | NDA AUTHORIZED GENERIC | Current |
| 74074-004 | Meclizine Hydrochloride | Meclizine Hydrochloride | Nortic Pharma, LLC | NDA AUTHORIZED GENERIC | Current |