Home NDC 23155-943 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205136-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 A205136-002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 A205136-003 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2019-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205136-003 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.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2019-02-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2019-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL 2019-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205136-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL 2019-02-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205136-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL 2019-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205136-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2019-02-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 Ingredient Strength MECLIZINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HDP7W44CIO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995686 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 23155-943-01 23155094301 100 TABLET in 1 BOTTLE (23155-943-01) 100 tablet 2026-06-25 No No Current 23155-943-10 23155094310 1000 TABLET in 1 PACKAGE (23155-943-10) 1000 tablet 2026-06-25 No No Current