Meclizine Hydrochloride

Product NDC
53746-442
11-digit product format
537460442
Labeler code
53746
Product ID
53746-442_d4732fb5-fb04-4933-8ecc-98ab55184b54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA201451
Marketing category
ANDA
Marketing start
2022-04-22
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Meclizine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995624Internal RxNorm lookup
995666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff719d9c-8d80-42db-97a5-022a75773623Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-442-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1004
53746-442-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-442-01EA - Each53746-44295b55b48-d25f-45bc-a6c6-e84807886e9812022-10-06
53746-442-10EA - Each53746-442f582f9e0-dbbc-44d9-ba96-58a8f20a337a12022-10-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-442MECLIZINE HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]3Current NDC, Legacy NDC, 2 package rows20240114_ff719d9c-8d80-42db-97a5-022a75773623.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 · 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
ndc (product): 53746-442
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine HCl 25 MG Oral TabletPSNaf5d0c9b-a997-8033-afca-3c04221f2e7611
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine hydrochloride 25 MG Oral TabletSCDaf5d0c9b-a997-8033-afca-3c04221f2e7611
995666meclizine HCl 25 MG Oral TabletPSN2df6edde-4479-ed9d-e063-6394a90abdc16
995666meclizine hydrochloride 25 MG Oral TabletSCD2df6edde-4479-ed9d-e063-6394a90abdc16
995624meclizine HCl 12.5 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995624meclizine HCl 12.5 MG Oral TabletPSNf99f13ab-33c0-4304-8dc5-3a75f39093775
995666meclizine HCl 25 MG Oral TabletPSNaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine HCl 25 MG Oral TabletPSNf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine hydrochloride 12.5 MG Oral TabletSCDf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine hydrochloride 12.5 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine hydrochloride 25 MG Oral TabletSCDaf1e45ca-1478-4eeb-8fdc-4f3d3eda4ed55
995666meclizine hydrochloride 25 MG Oral TabletSCDf99f13ab-33c0-4304-8dc5-3a75f39093775
995624meclizine HCl 12.5 MG Oral TabletPSNff719d9c-8d80-42db-97a5-022a757736234
995666meclizine HCl 25 MG Oral TabletPSNff719d9c-8d80-42db-97a5-022a757736234
995624meclizine hydrochloride 12.5 MG Oral TabletSCDff719d9c-8d80-42db-97a5-022a757736234
995666meclizine hydrochloride 25 MG Oral TabletSCDff719d9c-8d80-42db-97a5-022a757736234
995666meclizine HCl 25 MG Oral TabletPSN1b541252-e8a7-b678-e063-6394a90a34dc3
995666meclizine hydrochloride 25 MG Oral TabletSCD1b541252-e8a7-b678-e063-6394a90a34dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-442-0153746044201100 TABLET in 1 BOTTLE (53746-442-01) 100 tablet2022-04-220000-00-00NoNoCurrent
53746-442-10537460442101000 TABLET in 1 BOTTLE (53746-442-10) 1000 tablet2022-04-220000-00-00NoNoCurrent