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 4 of 5 · 85 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MECLIZINE HYDROCHLORIDE MECLIZINE A-S Medication Solutions 55e262d9-d9dd-43a3-bc74-35e46dd391be 2024-10-30 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE A-S Medication Solutions 949f7347-8c3a-43ce-b975-8d187096f09f 2024-10-30 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE DRAMAMINE - N MECLIZINE HYDROCHLORIDE Medtech Products Inc. 7fec7791-c242-4e43-8184-32820e657afb 2024-10-25 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE DRAMAMINE MECLIZINE HYDROCHLORIDE Medtech Products Inc. f8cf751a-9f19-4744-a350-cd22303435ee 2024-10-25 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE NCS HealthCare of KY, LLC dba Vangard Labs 1a33dec1-8d59-48bd-aaef-77d162194d57 2024-08-08 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Proficient Rx LP 92e8390b-5173-4aa1-906d-35d2c0eaaaf6 2024-08-01 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCLORIDE NuCare Pharmaceuticals,Inc. 64a508ae-768a-2fba-e053-2991aa0ac42d 2024-07-17 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 199ae195-4556-ee88-e063-6394a90a40d4 2024-06-10 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Direct_Rx e79ecf77-0e0a-d7ef-e053-2a95a90a5adf 2024-04-09 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Asclemed USA, Inc. e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db 2024-04-08 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Zydus Pharmaceuticals (USA) Inc. 947a03c5-bca0-4d97-90b9-bcd6d6588273 2024-03-22 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE A-S Medication Solutions eae4bc73-fee1-4831-b31c-8ca56fb83ad7 2023-12-03 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine HCl MECLIZINE HYDROCHLORIDE BluePoint Laboratories d9cae5a6-8d4b-bdaf-e053-2995a90a7d44 2023-11-17 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE ZenTrip Motion Sickness MECLIZINE HYDROCHLORIDE Sato Pharmaceutical Co., LTD bd86c4c7-b6f0-e3e8-e053-2995a90a4454 2023-11-03 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE Amneal Pharmaceuticals LLC 666dc4d8-7b16-4c3c-84e4-645548dbee68 2023-09-28 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Aurobindo Pharma Limited beb3c7f2-c0f4-41d9-a903-63a6847e0997 2023-09-15 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Zydus Lifesciences Limited cf157a71-f80a-4fb7-b892-7102b65a8ec0 2023-08-28 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE A-S Medication Solutions 51c96c7a-0a38-41a5-a6c9-7f45db65fdda 2023-04-19 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Proficient Rx LP b91435d1-fb95-4939-8478-84e41f44f732 2023-04-01 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Proficient Rx LP 6a8cbc12-0725-4462-bb71-0b18cefc19e7 2023-01-01 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE 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