MECLIZINE HYDROCHLORIDE

Product NDC
23155-943
11-digit product format
231550943
Labeler code
23155
Product ID
23155-943_eb857fbb-87f5-41dc-941a-21f6fb8df1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205136
Marketing category
ANDA
Marketing start
2026-06-25
Substance
MECLIZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205136-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORAL2019-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A205136-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORAL2019-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A205136-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2019-02-2284e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A205136-003AA184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995686Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b11c10b9-f40e-4ea7-9c5d-118517049f9dAvailable on FDA.report

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
ndc (product): 23155-943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-943-0123155094301100 TABLET in 1 BOTTLE (23155-943-01) 100 tablet2026-06-25NoNoCurrent
23155-943-10231550943101000 TABLET in 1 PACKAGE (23155-943-10) 1000 tablet2026-06-25NoNoCurrent