Home NDC 62135-952 Meclizine Hydrochloride
Product NDC 62135-952
11-digit product format 621350952
Labeler code 62135
Product ID 62135-952_30511729-d20f-8726-e063-6394a90a6053
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA203003
Marketing category ANDA
Marketing start 2022-08-11
Substance MECLIZINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A203003-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 A203003-002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 A203003-003 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-02-19 14:30 UTC 2026-02 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203003-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2022-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203003-003 MECLIZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2022-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203003-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2022-08-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Meclizine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MECLIZINE HYDROCHLORIDE 12.5 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995624 Internal RxNorm lookup 995666 Internal RxNorm lookup 995686 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-952-90 Meclizine Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-952 MECLIZINE HYDROCHLORIDE TABLET, FILM COATED [CHARTWELL RX, LLC] 3 Current NDC, 1 package rows 20250321_87d4c6d8-9218-48c2-9163-615a32449f11.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-952-90 62135095290 90 TABLET, FILM COATED in 1 BOTTLE (62135-952-90) 2025-03-04 No No Current