FDA.reportPublic FDA data

NDC 59746-433-04 - Zolmitriptan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59746-433
Requested NDC
59746-433-04
Package NDCs from labels
59746-433-04, 59746-433-13, 59746-433-16, 59746-433-15, 59746-433-17
Manufacturer
Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited
Effective date
2021-01-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zolmitriptan - Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics LimitedJubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited2021-01-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59746-433-132026-01-05These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-152026-01-05These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-162026-01-05These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-172026-01-05These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-132023-01-30These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-152023-01-30These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-162023-01-30These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
59746-433-172023-01-30These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-433ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]6Legacy NDC20210116_8b4fe798-ccbd-e0cc-d219-5a70d8115f43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-433-04EA - Each59746-4334826b4e3-da55-482e-b858-499cdc8a199412015-07-20
59746-433-13EA - Each59746-433bbcbbd3a-8f20-49e5-b8bd-d7e0078146f812015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
HypromellosesINACTIVE INGREDIENT3NXW29V3WOZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Polyethylene Glycol 8000INACTIVE INGREDIENTQ662QK8M3BZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4

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 2 of 112 · 2,226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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