MECLIZINE HYDROCHLORIDE

Product NDC
59651-808
11-digit product format
596510808
Labeler code
59651
Product ID
59651-808_beb3c7f2-c0f4-41d9-a903-63a6847e0997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MECLIZINE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202640
Marketing category
ANDA
Marketing start
2023-09-14
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 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
A202640-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17
A202640-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17
A202640-003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202640-001AA
A202640-002AA
A202640-003AA

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 UTC2026-02A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2012-09-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-003MECLIZINE HYDROCHLORIDE50MGTABLET / ORALAA2012-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202640-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2012-09-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202640-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202640-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202640-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202640-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202640-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202640-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202640-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202640-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202640-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202640-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202640-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202640-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202640-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202640-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202640-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202640-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202640-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202640-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202640-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202640-001AA18072bd15b7f6…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995624Internal RxNorm lookup
995666Internal RxNorm lookup
995686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
beb3c7f2-c0f4-41d9-a903-63a6847e0997Available 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
59651-808-01MECLIZINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
59651-808-99MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-808-01EA - Each59651-808de669a10-970e-4a34-bafb-fe8c6b93b1a412024-03-12
59651-808-99EA - Each59651-8089a73a188-3a72-4d42-b04e-7089cd551f8012024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-808MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230920_beb3c7f2-c0f4-41d9-a903-63a6847e0997.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 HYDROCHLORIDEMECLIZINEPreferred Pharmaceuticals Inc.f755f8f3-7645-433c-b502-c1f15b7002992026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepackdab43efd-bec6-472f-b13a-1c043914dcd12026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepack1079db3f-d8ad-4c25-aa91-8ac8054ee4f22026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINERedpharm Drug52ee9258-8311-e6bd-e063-6294a90a567f2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINERedpharm Drug4727e7a9-eabb-a2a7-e063-6394a90a87542026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions55e262d9-d9dd-43a3-bc74-35e46dd391be2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEA-S Medication Solutions949f7347-8c3a-43ce-b975-8d187096f09f2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINENCS HealthCare of KY, LLC dba Vangard Labs1a33dec1-8d59-48bd-aaef-77d162194d572024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
MECLIZINE HYDROCHLORIDEMECLIZINEAurobindo Pharma Limitedbeb3c7f2-c0f4-41d9-a903-63a6847e09972023-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202640
application number: ANDA202640
ndc (product): 59651-808

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN4727e7a9-eabb-a2a7-e063-6394a90a87542
995666meclizine HCl 25 MG Oral TabletPSN55e262d9-d9dd-43a3-bc74-35e46dd391be2
995666meclizine hydrochloride 25 MG Oral TabletSCD4727e7a9-eabb-a2a7-e063-6394a90a87542
995666meclizine hydrochloride 25 MG Oral TabletSCD55e262d9-d9dd-43a3-bc74-35e46dd391be2
995624meclizine HCl 12.5 MG Oral TabletPSN1a33dec1-8d59-48bd-aaef-77d162194d571
995624meclizine HCl 12.5 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995666meclizine HCl 25 MG Oral TabletPSN1a33dec1-8d59-48bd-aaef-77d162194d571
995666meclizine HCl 25 MG Oral TabletPSN949f7347-8c3a-43ce-b975-8d187096f09f1
995666meclizine HCl 25 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995686meclizine HCl 50 MG Oral TabletPSNbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995624meclizine hydrochloride 12.5 MG Oral TabletSCD1a33dec1-8d59-48bd-aaef-77d162194d571
995624meclizine hydrochloride 12.5 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995666meclizine hydrochloride 25 MG Oral TabletSCD1a33dec1-8d59-48bd-aaef-77d162194d571
995666meclizine hydrochloride 25 MG Oral TabletSCD949f7347-8c3a-43ce-b975-8d187096f09f1
995666meclizine hydrochloride 25 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971
995686meclizine hydrochloride 50 MG Oral TabletSCDbeb3c7f2-c0f4-41d9-a903-63a6847e09971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-808-0159651080801100 TABLET in 1 BOTTLE (59651-808-01) 100 tablet2023-09-14NoNoCurrent
59651-808-99596510808991000 TABLET in 1 BOTTLE (59651-808-99) 1000 tablet2023-09-14NoNoCurrent