Home NDC 63187-258 Meclizine Hydrochloride
Product NDC 63187-258
11-digit product format 631870258
Labeler code 63187
Product ID 63187-258_9a01be91-ff05-4f46-92d4-68b2d1db251c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA200294
Marketing category ANDA
Marketing start 2012-04-30
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 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 42 .
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 A200294-001 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 A200294-002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13
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 · 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 2026-08-18 06:07:40 2026-07 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 25 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995666 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 63187-258-10 Meclizine Hydrochloride 10 in 1 BOTTLE TABLET 10 5 63187-258-20 Meclizine Hydrochloride 20 in 1 BOTTLE TABLET 20 5 63187-258-30 Meclizine Hydrochloride 30 in 1 BOTTLE TABLET 30 5 63187-258-60 Meclizine Hydrochloride 60 in 1 BOTTLE TABLET 60 5 63187-258-90 Meclizine Hydrochloride 90 in 1 BOTTLE TABLET 90 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-258 MECLIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 5 package rows 20210116_91b1fd1a-1da2-4aae-826f-7de0bfe62161.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63187-258-10 63187025810 10 TABLET in 1 BOTTLE (63187-258-10) 10 tablet 2019-01-01 0000-00-00 No No Current 63187-258-20 63187025820 20 TABLET in 1 BOTTLE (63187-258-20) 20 tablet 2019-01-01 0000-00-00 No No Current 63187-258-30 63187025830 30 TABLET in 1 BOTTLE (63187-258-30) 30 tablet 2019-01-01 0000-00-00 No No Current 63187-258-60 63187025860 60 TABLET in 1 BOTTLE (63187-258-60) 60 tablet 2019-01-01 0000-00-00 No No Current 63187-258-90 63187025890 90 TABLET in 1 BOTTLE (63187-258-90) 90 tablet 2019-01-01 0000-00-00 No No Current