Meclizine Hydrochloride

Product NDC
68084-491
Requested package NDC
68084-491-01
11-digit product format
680840491
Labeler code
68084
Product ID
68084-491_ea3fb07f-0003-8a55-e053-2a95a90a8243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA201451
Marketing category
ANDA
Marketing start
2011-07-14
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68084-49168084-491-01DDiscontinued by firm2026-08-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201451-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23
A201451-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23
A201451-003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201451-001AA
A201451-002AA
A201451-003AA

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAARS2011-02-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2011-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201451-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAARS2011-02-238072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201451-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201451-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201451-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201451-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201451-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201451-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201451-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201451-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201451-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201451-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201451-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201451-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201451-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201451-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201451-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201451-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201451-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201451-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201451-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201451-001AA18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-491-01EA - Each68084-491f37acac5-ba7b-41ea-9f8b-57b2cd8b873e12012-07-24
68084-491-11EA - Each68084-4911c2f3223-e891-4d08-a294-a59730dc045112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMECLIZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENorthwind Health Company, LLC1b541252-e8a7-b678-e063-6394a90a34dc2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEMajor Pharmaceuticalsf99f13ab-33c0-4304-8dc5-3a75f39093772026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEQPharma Inc2df6edde-4479-ed9d-e063-6394a90abdc12026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCff719d9c-8d80-42db-97a5-022a757736232026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINEAvPAKaf5d0c9b-a997-8033-afca-3c04221f2e762026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENorthwind Health Company, LLCf2b4716c-411a-62cd-e053-2a95a90a6f4b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEQPharma Inc18fe5e13-5583-45ee-ab6e-32e9af426bd82025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAmerican Health Packagingaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed52025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451
Meclizine HydrochlorideMECLIZINEAmneal Pharmaceuticals LLC666dc4d8-7b16-4c3c-84e4-645548dbee682023-09-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201451
application number: ANDA201451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-491-0168084049101100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-491-01) > 1 TABLET in 1 BLISTER PACK (68084-491-11) 100 blister pack2011-07-140000-00-00NoNoCurrent