Meclizine hydrochloride

Product NDC
52536-129
Requested package NDC
52536-129-01
11-digit product format
525360129
Labeler code
52536
Product ID
52536-129_c00045b2-67b8-4f8a-a1de-f76137acfc3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Wilshire Pharmaceuticals Inc
Application
ANDA205136
Marketing category
ANDA
Marketing start
2019-04-15
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52536-12952536-129-01DDiscontinued by firm2026-08-17

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.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205136-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22
A205136-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22
A205136-003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2019-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205136-003AA

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2019-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORAL2019-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2019-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2019-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2019-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2019-02-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205136-003AA1caaa826d4ba7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205136-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205136-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205136-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205136-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205136-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205136-002AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205136-003AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205136-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205136-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205136-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205136-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205136-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205136-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205136-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205136-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205136-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205136-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205136-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205136-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205136-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205136-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205136-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205136-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205136-003AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205136-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205136-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205136-003AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A205136-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205136-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A205136-003AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205136-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205136-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A205136-003AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205136-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205136-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A205136-003AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205136-001AA13f01610625f2…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-129-01EA - Each52536-129506e5e76-9e9a-4a59-b372-3a2559826b6112019-10-07

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b11c10b9-f40e-4ea7-9c5d-118517049f9d2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205136
application number: ANDA205136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52536-129-0152536012901100 TABLET in 1 BOTTLE (52536-129-01) 100 tablet2019-04-150000-00-00NoNoCurrent