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 1 .
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 2 · 77 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 77 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 1 of 5 · 88 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MECLIZINE HYDROCHLORIDE MECLIZINE Preferred Pharmaceuticals Inc. f755f8f3-7645-433c-b502-c1f15b700299 2026-08-03 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Bryant Ranch Prepack dab43efd-bec6-472f-b13a-1c043914dcd1 2026-07-27 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Rugby Laboratories b57f14a7-3852-03db-e053-2a95a90a80d6 2026-07-16 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Northwind Health Company, LLC 1b541252-e8a7-b678-e063-6394a90a34dc 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCLORIDE REMEDYREPACK INC. ba2fb6de-af86-4c05-9018-135e1f8594f9 2026-07-03 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. b11c10b9-f40e-4ea7-9c5d-118517049f9d 2026-06-25 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE DRAMAMINE CHEWABLE ORANGE MECLIZINE HYDROCHLORIDE Medtech Products Inc. 30387e63-278d-412a-bcad-7965c7c0aea7 2026-06-23 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE St. Mary's Medical Park Pharmacy c6b3f4d8-5fcf-2278-e053-2a95a90ab139 2026-06-21 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Preferred Pharmaceuticals Inc. d7d31433-8f39-4fe6-b542-1b4410122db7 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Redpharm Drug 53df5b1b-64da-e805-e063-6294a90a0a55 2026-06-10 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Bryant Ranch Prepack 1079db3f-d8ad-4c25-aa91-8ac8054ee4f2 2026-06-08 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Redpharm Drug 52ee9258-8311-e6bd-e063-6294a90a567f 2026-05-29 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 81e1762b-e012-4c6d-96e6-9a9f27a1880a 2026-05-27 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Major Pharmaceuticals f99f13ab-33c0-4304-8dc5-3a75f3909377 2026-05-26 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE REMEDYREPACK INC. 21d4a6ee-0a66-45d7-bab9-c5eef399713d 2026-05-13 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE QPharma Inc 2df6edde-4479-ed9d-e063-6394a90abdc1 2026-05-11 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE Redpharm Drug 4727e7a9-eabb-a2a7-e063-6394a90a8754 2026-05-05 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE REMEDYREPACK INC. d53bf04e-5cfc-4974-9b24-2cce545d1bd0 2026-04-15 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. c31846b2-d47d-a97b-e053-2a95a90a9bec 2026-03-27 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. beb36d86-9fb7-1f60-e053-2995a90aac13 2026-03-02 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE
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