Home Applications 084657 Application 084657
Type ANDA
Sponsor ANI PHARMS INC 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 A084657-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 A084657-002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982
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 · 84 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 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A084657-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A084657-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL Approved before 1982 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 2 of 5 · 85 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 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 Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Amneal Pharmaceuticals of New York LLC ff719d9c-8d80-42db-97a5-022a75773623 2026-03-01 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Dramamine Less Drowsy MECLIZINE HYDROCHLORIDE Navajo Manufacturing Company Inc. 4b203479-ba8d-7237-e063-6294a90ae6cb 2026-02-18 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. d0d8b376-8fe9-8776-e053-2a95a90ae651 2026-01-27 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Northwind Health Company, LLC c443873a-2e89-43b2-b145-dde3dadf7bc0 2026-01-19 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE AvPAK af5d0c9b-a997-8033-afca-3c04221f2e76 2026-01-08 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Northwind Health Company, LLC f2b4716c-411a-62cd-e053-2a95a90a6f4b 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE CVS Motion Sickness Fast Melting MECLIZINE HYDROCHLORIDE CVS Pharmacy, Inc. 2a723bce-a581-4558-b028-22f1f9125dd5 2025-12-30 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Wal-Dram 2 Quick-Dissolving MECLIZINE HYDROCHLORIDE Walgreen Co. f3116203-1b8f-438a-b779-7bdd90eaf79e 2025-12-30 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE Redpharm Drug 37457bd5-2fdd-b829-e063-6294a90a04f0 2025-12-24 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE DRAMAMINE MECLIZINE HYDROCHLORIDE Medtech Products Inc. fdcbcc4e-9370-4975-8905-1f12c73fdc8c 2025-12-23 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE DRAMAMINE MECLIZINE HYDROCHLORIDE Medtech Products Inc. 3a960d43-62aa-464e-92b9-d83042ba02bf 2025-12-23 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE DRAMAMINE MECLIZINE HYDROCHLORIDE Medtech Products Inc. 6efd3473-ee14-4ee0-8a58-d15a64a9224a 2025-12-18 Warnings Name fallback generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE QPharma Inc 18fe5e13-5583-45ee-ab6e-32e9af426bd8 2025-12-03 Warnings, Adverse reactions Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 522b55a2-313c-45e8-b1be-07746ada5b0a 2025-10-31 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE generic name: MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE CVS Pharmacy, Inc b57fc6c2-fbfc-24c3-e053-2995a90a3389 2025-10-16 Warnings Name fallback brand name: Meclizine Hydrochloride generic name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCLORIDE Bryant Ranch Prepack f43bf077-3f29-48ec-8ca8-eb294dbf2001 2025-09-16 Warnings, Adverse reactions Name fallback brand name: MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE Bryant Ranch Prepack 6dd657ba-46dc-4106-9f6a-dfa0ecf85752 2025-09-11 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51407-629 Meclizine Hydrochloride Meclizine Hydrochloride Golden State Medical Supply, Inc. ANDA Current 60760-842 Meclizine Hydrochloride Meclizine Hydrochloride St. Mary's Medical Park Pharmacy ANDA Current 62559-841 Meclizine Hydrochloride Meclizine Hydrochloride ANI Pharmaceuticals, Inc. ANDA Current 62559-842 Meclizine Hydrochloride Meclizine Hydrochloride ANI Pharmaceuticals, Inc. ANDA Current 68071-2697 Meclizine Hydrochloride Meclizine Hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 68071-2697 Meclizine Hydrochloride Meclizine Hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 68071-2817 Meclizine Hydrochloride Meclizine Hydrochloride NuCare Pharmaceuticals,Inc. ANDA Current 71335-2137 Meclizine Hydrochloride Meclizine Hydrochloride Bryant Ranch Prepack ANDA Current 71335-9619 Meclizine Hydrochloride Meclizine Hydrochloride Bryant Ranch Prepack ANDA Current