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 1 of 112 · 2,239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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