Home NDC 12634-424-78 Meclizine Hydrochloride
Product NDC 12634-424
Requested package NDC 12634-424-78
11-digit product format 126340424
Labeler code 12634
Product ID 12634-424_46f1e0ac-d67e-4419-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Apotheca Inc.
Application ANDA200294
Marketing category ANDA
Marketing start 2012-04-30
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…
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 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 · 82 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 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…2021-12-28 21:50 UTC 2021-12 A200294-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA 2012-04-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200294-002 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-04-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 12634-424-00 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-01 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-09 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-12 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-18 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-40 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-42 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-45 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-50 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-52 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-54 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-57 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-59 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-60 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-61 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-63 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-66 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-67 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-69 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-71 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-74 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-78 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-79 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-80 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-81 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-82 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-84 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-85 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-90 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-91 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-92 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-93 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-94 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-95 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-96 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-97 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-98 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only 12634-424-99 Meclizine Hydrochloride Tablets USP, 25 mg Rx Only
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-424 MECLIZINE HYDROCHLORIDE TABLET [APOTHECA INC.] 1 Legacy NDC, 38 package rows 20170126_46f1e0ac-d67d-4419-e054-00144ff88e88.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 12634-424-78 12634042478 28 TABLET in 1 BOTTLE (12634-424-78) 28 tablet 2012-04-30 0000-00-00 No No Current