Meclizine Hydrochloride

Product NDC
70710-1162
11-digit product format
707101162
Labeler code
70710
Product ID
70710-1162_f084de6d-5e11-4c6e-8643-d0a4a48fc4da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213957
Marketing category
ANDA
Marketing start
2020-10-29
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213957-001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23
A213957-002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213957-001AA
A213957-002AA

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213957-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAA2020-06-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213957-002MECLIZINE HYDROCHLORIDE25MGTABLET / ORALAA2020-06-2387673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213957-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213957-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213957-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213957-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213957-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213957-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213957-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213957-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213957-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213957-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213957-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213957-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213957-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213957-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213957-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213957-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213957-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213957-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213957-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213957-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213957-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213957-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213957-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213957-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213957-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213957-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213957-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213957-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213957-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213957-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213957-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213957-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213957-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213957-002AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213957-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213957-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213957-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213957-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213957-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213957-002AA187673890dc5c…

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 · 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
947a03c5-bca0-4d97-90b9-bcd6d6588273Available 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
70710-1162-0Meclizine Hydrochloride1000 in 1 BOTTLETABLET10003
70710-1162-1Meclizine Hydrochloride100 in 1 BOTTLETABLET1003
70710-1162-2Meclizine Hydrochloride10 in 1 BLISTER PACKTABLET103
70710-1162-3Meclizine Hydrochloride30 in 1 BOTTLETABLET303
70710-1162-4Meclizine Hydrochloride10 in 1 CARTONTABLET103
70710-1162-9Meclizine Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1162-0EA - Each70710-1162084bd0b1-fcb9-4d92-a42e-b55592f8f0ee12021-01-08
70710-1162-1EA - Each70710-11627e2a4706-b90f-4b60-a2b7-7e3dd8a0bb6a12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1162MECLIZINE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, Legacy NDC, 6 package rows20240323_947a03c5-bca0-4d97-90b9-bcd6d6588273.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERedpharm Drug53df5b1b-64da-e805-e063-6294a90a0a552026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERedpharm Drug37457bd5-2fdd-b829-e063-6294a90a04f02025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.2990e296-2d60-70c0-e063-6394a90abbe42025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.2e0ed1fc-53e6-a3b1-e063-6394a90af4192025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.947a03c5-bca0-4d97-90b9-bcd6d65882732024-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
ndc (product): 70710-1162
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutionseae4bc73-fee1-4831-b31c-8ca56fb83ad72023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEZydus Lifesciences Limitedcf157a71-f80a-4fb7-b892-7102b65a8ec02023-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions51c96c7a-0a38-41a5-a6c9-7f45db65fdda2023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213957
application number: ANDA213957

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNeae4bc73-fee1-4831-b31c-8ca56fb83ad77
995666meclizine hydrochloride 25 MG Oral TabletSCDeae4bc73-fee1-4831-b31c-8ca56fb83ad77
995624meclizine HCl 12.5 MG Oral TabletPSN947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine HCl 25 MG Oral TabletPSN37457bd5-2fdd-b829-e063-6294a90a04f03
995666meclizine HCl 25 MG Oral TabletPSN947a03c5-bca0-4d97-90b9-bcd6d65882733
995624meclizine hydrochloride 12.5 MG Oral TabletSCD947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine hydrochloride 25 MG Oral TabletSCD37457bd5-2fdd-b829-e063-6294a90a04f03
995666meclizine hydrochloride 25 MG Oral TabletSCD947a03c5-bca0-4d97-90b9-bcd6d65882733
995666meclizine HCl 25 MG Oral TabletPSN2990e296-2d60-70c0-e063-6394a90abbe42
995666meclizine hydrochloride 25 MG Oral TabletSCD2990e296-2d60-70c0-e063-6394a90abbe42
995666meclizine HCl 25 MG Oral TabletPSN2e0ed1fc-53e6-a3b1-e063-6394a90af4191
995666meclizine HCl 25 MG Oral TabletPSN51c96c7a-0a38-41a5-a6c9-7f45db65fdda1
995666meclizine hydrochloride 25 MG Oral TabletSCD2e0ed1fc-53e6-a3b1-e063-6394a90af4191
995666meclizine hydrochloride 25 MG Oral TabletSCD51c96c7a-0a38-41a5-a6c9-7f45db65fdda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1162-0707101162001000 TABLET in 1 BOTTLE (70710-1162-0) 1000 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-170710116201100 TABLET in 1 BOTTLE (70710-1162-1) 100 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-27071011620210 in 1 BLISTER PACKHistorical
70710-1162-37071011620330 TABLET in 1 BOTTLE (70710-1162-3) 30 tablet2020-10-290000-00-00NoNoCurrent
70710-1162-47071011620410 BLISTER PACK in 1 CARTON (70710-1162-4) / 10 TABLET in 1 BLISTER PACK (70710-1162-2) 10 blister pack2020-10-290000-00-00NoNoCurrent
70710-1162-97071011620990 TABLET in 1 BOTTLE (70710-1162-9) 90 tablet2020-10-290000-00-00NoNoCurrent