FDA.reportPublic FDA data

Application 010721

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL50MGYesNo
004ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL25MGYesNo
005ANTIVERTMECLIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL25MGYesNo
006ANTIVERTMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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N010721-001ANTIVERTMECLIZINE HYDROCHLORIDE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20
N010721-004ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982
N010721-005ANTIVERTMECLIZINE HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982
N010721-006ANTIVERTMECLIZINE HYDROCHLORIDE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N010721-001ANTIVERT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, RS1982-01-20a50c72e98297…
2026-08-01 22:54:322026-06N010721-004ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N010721-005ANTIVERT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N010721-006ANTIVERT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALAARLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N010721-001AA1a50c72e98297…
2026-08-01 22:54:322026-06N010721-004AA1a50c72e98297…
2026-08-01 22:54:322026-06N010721-006AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 60760-661
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 HYDROCHLORIDEREMEDYREPACK INC.21d4a6ee-0a66-45d7-bab9-c5eef399713d2026-05-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.d53bf04e-5cfc-4974-9b24-2cce545d1bd02026-04-15Warnings, 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
ndc (product): 68071-2416
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.beb36d86-9fb7-1f60-e053-2995a90aac132026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 68071-2380
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack112103bc-25e2-42cf-8542-ba1d3392a2c32025-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 71335-1872
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
ndc (product): 16571-662
ndc (product): 16571-663
ndc (product): 16571-661
ndc (product): 16571-660
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
ndc (product): 72189-302
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP92e8390b-5173-4aa1-906d-35d2c0eaaaf62024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 71205-647
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEDirect_Rxe79ecf77-0e0a-d7ef-e053-2a95a90a5adf2024-04-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 010721
application number: NDA010721
ndc (product): 72189-237
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-660Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-660Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-661Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-661Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-662Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-662Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-663Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
16571-663Meclizine HydrochlorideMeclizine HydrochlorideRising Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55700-912Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-919Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-919Meclizine HydrochlorideMeclizine HydrochlorideQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
60760-661Meclizine HydrochlorideMeclizine HydrochlorideSt. Mary's Medical Park PharmacyNDA AUTHORIZED GENERICCurrent
67296-1432Meclizine HydrochlorideMeclizine HydrochlorideRedPharm Drug, Inc.NDA AUTHORIZED GENERICCurrent
68071-2380Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-2416Meclizine HydrochlorideMeclizine HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
70199-002Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-002Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-003Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-003Antivertmeclizine HClCasper Pharma LLCNDACurrent
70199-004Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-004Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-018Antivertmeclizine hclCasper Pharma LLCNDACurrent
70199-018Antivertmeclizine hclCasper Pharma LLCNDACurrent
71205-647Meclizine HydrochlorideMeclizine HydrochlorideProficient Rx LPNDA AUTHORIZED GENERICCurrent
71335-1825Meclizine HydrochlorideMeclizine HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1872Meclizine HydrochlorideMeclizine HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-237MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDIRECT RXNDA AUTHORIZED GENERICCurrent
72189-237Meclizine HydrochlorideMeclizine HydrochlorideDirect_RxNDA AUTHORIZED GENERICCurrent
72189-302MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxNDA AUTHORIZED GENERICCurrent
72189-302MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEDirectRxNDA AUTHORIZED GENERICCurrent
74074-003Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-003Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-004Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent
74074-004Meclizine HydrochlorideMeclizine HydrochlorideNortic Pharma, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59240SUPPL2019-07-05
59203SUPPL2019-07-01
58931SUPPL2019-06-03
56855SUPPL2018-12-20
56729SUPPL2018-12-13
53694SUPPL2018-04-16
53682SUPPL2018-04-16
33027SUPPL2012-10-24
234SUPPL2012-10-24