Meclizine Hydrochloride
- Product NDC
- 70518-2304
- Requested package NDC
- 70518-2304-0
- 11-digit product format
- 705182304
- Labeler code
- 70518
- Product ID
- 70518-2304_ea4aff76-2a31-3f13-e053-2995a90a51db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201451
- Marketing category
- ANDA
- Marketing start
- 2019-09-09
- Marketing end
- 0000-00-00
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-2304 | 70518-2304-0 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201451-001 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 |
| A201451-002 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 |
| A201451-003 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201451-001 | AA |
| A201451-002 | AA |
| A201451-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | RS | 2011-02-23 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-003 | MECLIZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2011-02-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201451-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | RS | 2011-02-23 | 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 | A201451-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201451-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201451-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201451-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201451-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201451-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201451-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201451-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201451-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201451-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201451-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201451-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201451-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201451-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201451-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201451-001 | AA | 1 | 8072bd15b7f6… |
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 | Northwind Health Company, LLC | 1b541252-e8a7-b678-e063-6394a90a34dc | 2026-07-14 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Major Pharmaceuticals | f99f13ab-33c0-4304-8dc5-3a75f3909377 | 2026-05-26 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | QPharma Inc | 2df6edde-4479-ed9d-e063-6394a90abdc1 | 2026-05-11 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | ff719d9c-8d80-42db-97a5-022a75773623 | 2026-03-01 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE | AvPAK | af5d0c9b-a997-8033-afca-3c04221f2e76 | 2026-01-08 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Northwind Health Company, LLC | f2b4716c-411a-62cd-e053-2a95a90a6f4b | 2026-01-01 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | QPharma Inc | 18fe5e13-5583-45ee-ab6e-32e9af426bd8 | 2025-12-03 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | American Health Packaging | af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5 | 2025-06-23 | Warnings, Adverse reactions | 201451 ANDA201451 |
| Meclizine Hydrochloride | MECLIZINE | Amneal Pharmaceuticals LLC | 666dc4d8-7b16-4c3c-84e4-645548dbee68 | 2023-09-28 | Warnings, Adverse reactions | 201451 ANDA201451 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2304-0 | 70518230400 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2304-0) | 90 tablet | 2019-09-09 | 0000-00-00 | No | No | Current |