Home NDC 42806-012 Meclizine Hydrochloride
Product NDC 42806-012
11-digit product format 428060012
Labeler code 42806
Product ID 42806-012_42600718-075b-481b-8fec-cb6cbadab7de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Epic Pharma LLC
Application ANDA200294
Marketing category ANDA
Marketing start 2012-04-30
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 · 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.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995624 Internal RxNorm lookup 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 42806-012-01 Meclizine Hydrochloride 100 in 1 BOTTLE TABLET 100 12 42806-012-10 Meclizine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECLIZINE HYDROCHLORIDE ACTIVE INGREDIENT HDP7W44CIO MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 MECLIZINE ACTIVE MOIETY 3L5TQ84570 MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-012 MECLIZINE HYDROCHLORIDE TABLET [EPIC PHARMA LLC] 12 Current NDC, Legacy NDC, 2 package rows 20200822_467e464b-bbaf-4053-9136-39e47a92fa05.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 42806-012-01 42806001201 100 TABLET in 1 BOTTLE (42806-012-01) 100 tablet 2012-04-30 0000-00-00 No No Current 42806-012-10 42806001210 1000 TABLET in 1 BOTTLE (42806-012-10) 1000 tablet 2012-04-30 0000-00-00 No No Current