Zolmitriptan

Product NDC
59746-433
11-digit product format
597460433
Labeler code
59746
Product ID
59746-433_9f9ec6cf-1562-41a9-9219-7b993eeb175c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA202279
Marketing category
ANDA
Marketing start
2014-11-20
Marketing end
0000-00-00
Substance
ZOLMITRIPTAN
Active strength
5 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-433-13597460433131 BLISTER PACK in 1 CARTON (59746-433-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-433-04) 1 blister pack2014-11-200000-00-00NoNoCurrent
59746-433-15597460433151 BLISTER PACK in 1 CARTON (59746-433-15) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-11-200000-00-00NoNoCurrent
59746-433-16597460433162 BLISTER PACK in 1 CARTON (59746-433-16) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-433-04) 2 blister pack2014-12-200000-00-00NoNoCurrent
59746-433-17597460433172 BLISTER PACK in 1 CARTON (59746-433-17) > 3 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2014-11-200000-00-00NoNoCurrent