MECLIZINE HYDROCHLORIDE
- Product NDC
- 60760-087
- 11-digit product format
- 607600087
- Labeler code
- 60760
- Product ID
- 60760-087_ef545c37-addf-340f-e053-2995a90aad16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meclizine Hydrocloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA040659
- Marketing category
- ANDA
- Marketing start
- 2019-04-18
- 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 product | product | 60760-087 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 60760-087 | 60760-087-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 60760-087 | 60760-087-90 | D | Discontinued by firm | 2026-08-17 |
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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-087-30 | EA - Each | 60760-087 | 271543eb-6402-47ec-8e39-9dd11a8f8174 | 1 | 2019-11-12 |
| 60760-087-90 | EA - Each | 60760-087 | 88a3641e-e39b-45d0-9d9a-b37a55a95f2f | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
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 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | Northwind Health Company, LLC | c443873a-2e89-43b2-b145-dde3dadf7bc0 | 2026-01-19 | Warnings, Adverse reactions | 040659 ANDA040659 |
| Meclizine Hydrocloride | MECLIZINE HYDROCLORIDE | QPharma Inc | aa0fb895-a867-4482-9bc2-16eee8bfaaa0 | 2025-12-04 | Warnings, Adverse reactions | 040659 ANDA040659 |
| 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 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | Jubilant Cadista Pharmacuticals Inc. | 9350fefc-9c00-182c-c3a9-044d4a40856f | 2025-07-31 | Warnings, Adverse reactions | 040659 ANDA040659 |
| MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCLORIDE | NuCare Pharmaceuticals,Inc. | 64a508ae-768a-2fba-e053-2991aa0ac42d | 2024-07-17 | Warnings, Adverse reactions | 040659 ANDA040659 |
| 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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60760-087-30 | 60760008730 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-087-30) | 30 tablet | 2019-10-10 | 0000-00-00 | No | No | Current |
| 60760-087-90 | 60760008790 | 90 TABLET in 1 BOTTLE, PLASTIC (60760-087-90) | 90 tablet | 2019-04-18 | 0000-00-00 | No | No | Current |