Zolmitriptan

Product NDC
68001-250
11-digit product format
680010250
Labeler code
68001
Product ID
68001-250_4f68e4d5-c239-eb2d-e063-6294a90af478
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA201779
Marketing category
ANDA
Marketing start
2014-03-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FS66TH3YW
Rxcui200193, 200194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-250-01Zolmitriptan1 in 1 CARTONTABLET, FILM COATED17
68001-250-18Zolmitriptan3 in 1 BLISTER PACKTABLET, FILM COATED37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-250-01EA - Each68001-2503c19ae15-9a74-4f75-9686-ec744d21766212014-05-02
68001-250-18EA - Each68001-25076be2b0b-6e03-45aa-bd31-c40b39c1109b12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-250ZOLMITRIPTAN TABLET, FILM COATED [BLUEPOINT LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20200110_e6628b7a-0b63-4e6f-a5e7-2fa195265235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSNe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200194ZOLMitriptan 5 MG Oral TabletPSNe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200193zolmitriptan 2.5 MG Oral TabletSCDe6628b7a-0b63-4e6f-a5e7-2fa1952652357
200194zolmitriptan 5 MG Oral TabletSCDe6628b7a-0b63-4e6f-a5e7-2fa1952652357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-250-01680010250011 BLISTER PACK in 1 CARTON (68001-250-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (68001-250-18) 1 blister pack2014-03-130000-00-00NoNoCurrent
68001-250-18680010250183 in 1 BLISTER PACKHistorical