Home NDC 10544-108 Meclizine Hydrochloride
Product NDC 10544-108
11-digit product format 105440108
Labeler code 10544
Product ID 10544-108_e3fa8c4d-8fd6-4742-b8cc-5518f9b48cb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meclizine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA087128
Marketing category ANDA
Marketing start 2009-12-16
Marketing end 0000-00-00
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 2 · 77 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 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…2022-03-09 01:35 UTC 2022-03 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A087128-002 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087128-001 MECLIZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 77 observed states.
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 10544-108-15 Meclizine Hydrochloride 15 in 1 BOTTLE TABLET 15 3 10544-108-20 Meclizine Hydrochloride 20 in 1 BOTTLE TABLET 20 3 10544-108-30 Meclizine Hydrochloride 30 in 1 BOTTLE TABLET 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECLIZINE HYDROCHLORIDE ACTIVE INGREDIENT HDP7W44CIO MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 MECLIZINE ACTIVE MOIETY 3L5TQ84570 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-108 MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 3 Legacy NDC, 3 package rows 20140531_f1c072c1-5901-4c26-8ea1-c8a4c7ad570e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-108-15 10544010815 15 in 1 BOTTLE Historical 10544-108-20 10544010820 20 in 1 BOTTLE Historical 10544-108-30 10544010830 30 in 1 BOTTLE Historical