Meclizine Hydrochloride

Product NDC
71335-1825
11-digit product format
713351825
Labeler code
71335
Product ID
71335-1825_e1e6f9e4-9b01-4878-86ee-fc6c38b61932
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA010721
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-01-15
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010721-001ANTIVERTMECLIZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20
N010721-004ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982
N010721-005ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982
N010721-006ANTIVERTMECLIZINE HYDROCHLORIDE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N010721-001AA
N010721-004AA
N010721-006AA

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-2084e616aacf4f…
2026-09-14 22:38:342026-08N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 19825bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N010721-001AA184e616aacf4f…
2026-09-14 22:38:342026-08N010721-004AA184e616aacf4f…
2026-09-14 22:38:342026-08N010721-006AA184e616aacf4f…
2026-08-18 06:07:402026-07N010721-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N010721-004AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N010721-006AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N010721-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-004AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010721-006AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-004AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010721-006AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N010721-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-004AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010721-006AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-004AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010721-006AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-004AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010721-006AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-004AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010721-006AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-004AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010721-006AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-004AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010721-006AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-004AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010721-006AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N010721-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-004AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N010721-006AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-004AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010721-006AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010721-001AA1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
27b6a7e0-a361-4705-9f31-719063a65f22Available 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
71335-1825-0Meclizine Hydrochloride14 in 1 BOTTLETABLET14102
71335-1825-1Meclizine Hydrochloride90 in 1 BOTTLETABLET90102
71335-1825-2Meclizine Hydrochloride30 in 1 BOTTLETABLET30102
71335-1825-3Meclizine Hydrochloride25 in 1 BOTTLETABLET25102
71335-1825-4Meclizine Hydrochloride20 in 1 BOTTLETABLET20102
71335-1825-5Meclizine Hydrochloride40 in 1 BOTTLETABLET40102
71335-1825-6Meclizine Hydrochloride60 in 1 BOTTLETABLET60102
71335-1825-7Meclizine Hydrochloride120 in 1 BOTTLETABLET120102
71335-1825-8Meclizine Hydrochloride10 in 1 BOTTLETABLET10102
71335-1825-9Meclizine Hydrochloride100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1825-2EA - Each71335-1825d3b2094c-f9af-4a0c-b2a0-d7ab7f2fdc6212026-01-08
71335-1825-8EA - Each71335-18254efb9eab-8187-4f9c-bac7-2b729d4bf22012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1825MECLIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20230331_27b6a7e0-a361-4705-9f31-719063a65f22.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.21d4a6ee-0a66-45d7-bab9-c5eef399713d2026-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECoupler LLC598eb392-1dfe-c08c-e063-6394a90a4c7d2026-08-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d7d31433-8f39-4fe6-b542-1b4410122db72026-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack81e1762b-e012-4c6d-96e6-9a9f27a1880a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c31846b2-d47d-a97b-e053-2a95a90a9bec2026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.beb36d86-9fb7-1f60-e053-2995a90aac132026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack112103bc-25e2-42cf-8542-ba1d3392a2c32025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack27b6a7e0-a361-4705-9f31-719063a65f222025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 71335-1825
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERising Pharma Holdings, Inc.c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd2025-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2d31ae73-3f09-a77c-e063-6294a90ade9a2025-02-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxd27fe828-4fee-3ba9-e053-2995a90ae7b62025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP92e8390b-5173-4aa1-906d-35d2c0eaaaf62024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEDirect_Rxe79ecf77-0e0a-d7ef-e053-2a95a90a5adf2024-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAsclemed USA, Inc.e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db2024-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LPb91435d1-fb95-4939-8478-84e41f44f7322023-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN27b6a7e0-a361-4705-9f31-719063a65f22102
995666meclizine hydrochloride 25 MG Oral TabletSCD27b6a7e0-a361-4705-9f31-719063a65f22102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1825-07133518250014 TABLET in 1 BOTTLE (71335-1825-0) 14 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-17133518250190 TABLET in 1 BOTTLE (71335-1825-1) 90 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-27133518250230 TABLET in 1 BOTTLE (71335-1825-2) 30 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-37133518250325 TABLET in 1 BOTTLE (71335-1825-3) 25 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-47133518250420 TABLET in 1 BOTTLE (71335-1825-4) 20 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-57133518250540 TABLET in 1 BOTTLE (71335-1825-5) 40 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-67133518250660 TABLET in 1 BOTTLE (71335-1825-6) 60 tablet2022-02-240000-00-00NoNoCurrent
71335-1825-771335182507120 TABLET in 1 BOTTLE (71335-1825-7) 120 tablet2022-02-240000-00-00NoNoCurrent
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