Home NDC 50436-3988 Meclizine Hydrochloride
Product NDC 50436-3988
11-digit product format 504363988
Labeler code 50436
Product ID 50436-3988_2e9294f8-ef0b-40e2-a73c-13489d63fcd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meclizine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Unit Dose Services
Application ANDA087128
Marketing category ANDA
Marketing start 1981-06-03
Marketing end 0000-00-00
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 57 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 3 of 3 · 81 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A087128-002 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-3988-1 Meclizine Hydrochloride 30 in 1 BOTTLE TABLET 30 5 50436-3988-3 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 50436-3988 MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES] 5 Legacy NDC, 2 package rows 20171109_036f8929-ad15-4bfd-96d2-c2541170500b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-3988-1 50436398801 30 in 1 BOTTLE Historical 50436-3988-3 50436398803 90 in 1 BOTTLE Historical