MECLIZINE HYDROCHLORIDE

Product NDC
63187-996
11-digit product format
631870996
Labeler code
63187
Product ID
63187-996_6d44d894-810c-4608-a503-0cc6ff1f965d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrocloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040659-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04
A040659-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040659-001AA
A040659-002AA

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040659-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2010-06-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040659-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2010-06-04bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040659-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040659-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040659-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040659-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040659-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040659-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040659-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040659-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040659-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040659-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040659-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040659-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040659-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040659-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040659-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040659-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040659-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040659-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040659-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040659-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040659-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040659-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040659-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040659-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040659-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040659-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040659-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040659-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040659-002AA1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f574e123-8db7-4e3d-a0ee-e4e1f04ff146Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-996-10MECLIZINE HYDROCHLORIDE10 in 1 BOTTLETABLET106
63187-996-20MECLIZINE HYDROCHLORIDE20 in 1 BOTTLETABLET206
63187-996-30MECLIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET306
63187-996-60MECLIZINE HYDROCHLORIDE60 in 1 BOTTLETABLET606
63187-996-90MECLIZINE HYDROCHLORIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-996-10EA - Each63187-996640f5d90-6124-4eee-a812-82c7ea8ea96912020-08-06
63187-996-20EA - Each63187-99659b801ca-8f84-4b42-af4c-ba86273953e112018-05-09
63187-996-30EA - Each63187-9963ca4f632-f975-4f06-bc58-f7af9336200d12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-996MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 5 package rows20220701_f574e123-8db7-4e3d-a0ee-e4e1f04ff146.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEREMEDYREPACK INC.ba2fb6de-af86-4c05-9018-135e1f8594f92026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDENorthwind Health Company, LLCc443873a-2e89-43b2-b145-dde3dadf7bc02026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
Meclizine HydroclorideMECLIZINE HYDROCLORIDEQPharma Incaa0fb895-a867-4482-9bc2-16eee8bfaaa02025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack522b55a2-313c-45e8-b1be-07746ada5b0a2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEBryant Ranch Prepackf43bf077-3f29-48ec-8ca8-eb294dbf20012025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack6dd657ba-46dc-4106-9f6a-dfa0ecf857522025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack6c66ee38-10bb-4559-9d2f-51e6d6f091ee2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEJubilant Cadista Pharmacuticals Inc.9350fefc-9c00-182c-c3a9-044d4a40856f2025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDENuCare Pharmaceuticals,Inc.64a508ae-768a-2fba-e053-2991aa0ac42d2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEProficient Rx LP6a8cbc12-0725-4462-bb71-0b18cefc19e72023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEProficient Rx LPf574e123-8db7-4e3d-a0ee-e4e1f04ff1462022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
ndc (product): 63187-996
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEAsclemed USA, Inc.5c70e61b-a1e6-4981-92e2-1050cee08baa2020-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack53f410fd-104c-42c1-9740-6f48ffbc974f2020-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040659
application number: ANDA040659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNf574e123-8db7-4e3d-a0ee-e4e1f04ff1466
995666meclizine hydrochloride 25 MG Oral TabletSCDf574e123-8db7-4e3d-a0ee-e4e1f04ff1466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-996-106318709961010 TABLET in 1 BOTTLE (63187-996-10) 10 tablet2020-05-120000-00-00NoNoCurrent
63187-996-206318709962020 TABLET in 1 BOTTLE (63187-996-20) 20 tablet2018-03-010000-00-00NoNoCurrent
63187-996-306318709963030 TABLET in 1 BOTTLE (63187-996-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-996-606318709966060 TABLET in 1 BOTTLE (63187-996-60) 60 tablet2022-06-170000-00-00NoNoCurrent
63187-996-906318709969090 TABLET in 1 BOTTLE (63187-996-90) 90 tablet2022-06-170000-00-00NoNoCurrent