Home Applications 087128 Application 087128
Type ANDA
Sponsor AUREX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087128-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 A087128-002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 81 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 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
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 3 of 5 · 85 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Motion Sickness Relief MECLIZINE HYDROCHLORIDE TARGET CORPORATION 36ba2950-4a09-e5de-e063-6394a90a1771 2025-09-04 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 6c66ee38-10bb-4559-9d2f-51e6d6f091ee 2025-09-04 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 112103bc-25e2-42cf-8542-ba1d3392a2c3 2025-08-20 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 27b6a7e0-a361-4705-9f31-719063a65f22 2025-08-20 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCLORIDE Jubilant Cadista Pharmacuticals Inc. 9350fefc-9c00-182c-c3a9-044d4a40856f 2025-07-31 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE American Health Packaging af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5 2025-06-23 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Rising Pharma Holdings, Inc. c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd 2025-06-02 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE NuCare Pharmaceuticals, Inc. 2990e296-2d60-70c0-e063-6394a90abbe4 2025-05-15 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE BONINE MAX MECLIZINE HYDROCHLORIDE WellSpring Pharmaceutical Corporation 7326a47e-284e-4b6f-8eb0-7933dc1e3f0d 2025-04-11 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE BONINE MECLIZINE HYDROCHLORIDE WellSpring Pharmaceutical Corporation ad3d66ca-a52c-43ba-b9e2-6269b8a413a9 2025-03-21 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE BONINE MECLIZINE HYDROCHLORIDE WellSpring Pharmaceutical Corporation 0b2ea6b8-b342-4940-8922-898758fbeb31 2025-03-21 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Chartwell RX, LLC 87d4c6d8-9218-48c2-9163-615a32449f11 2025-03-14 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Walgreen Company ecf8d05e-0e77-f3e8-e053-2a95a90a6604 2025-03-11 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE NuCare Pharmaceuticals, Inc. 2e0ed1fc-53e6-a3b1-e063-6394a90af419 2025-02-13 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Advanced Rx of Tennessee, LLC 2d31ae73-3f09-a77c-e063-6294a90ade9a 2025-02-02 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE DirectRx d27fe828-4fee-3ba9-e053-2995a90ae7b6 2025-01-20 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE APNAR PHARMA LP e4d785a7-a688-3acb-e053-2a95a90a6d2e 2025-01-09 Boxed warning, Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE APNAR PHARMA LP ed43bf21-f3da-245c-e053-2995a90a504c 2025-01-09 Boxed warning, Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine MECLIZINE HYDROCHLORIDE Advanced Rx LLC b0a2a1f7-354e-48bd-9e98-9207bf9f53fd 2024-11-27 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine HCl MECLIZINE HYDROCHLORIDE Rising Pharma Holdings, Inc. acdf636c-66f1-4a1f-87a8-786f51d75708 2024-11-13 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0440-1736 Meclizine Hydrochloride meclizine hydrochloride Liberty Pharmaceuticals, Inc. ANDA Current 0615-1554 Meclizine Hydrochloride meclizine hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 10544-108 Meclizine Hydrochloride meclizine hydrochloride Blenheim Pharmacal, Inc. ANDA Current 21695-237 Meclizine Hydrochloride Meclizine Hydrochloride Rebel Distributors Corp. ANDA Current 49884-035 Meclizine Hydrochloride meclizine hydrochloride Par Pharmaceutical, Inc. ANDA Current 49884-035 Meclizine Hydrochloride meclizine hydrochloride Par Pharmaceutical, Inc. ANDA Current 50436-3988 Meclizine Hydrochloride meclizine hydrochloride Unit Dose Services ANDA Current 51655-134 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Northwind Pharmaceuticals, LLC ANDA Current 53808-0380 Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE State of Florida DOH Central Pharmacy ANDA Current 60429-205 Meclizine Hydrochloride meclizine hydrochloride Golden State Medical Supply, Inc. ANDA Current