Zolmitriptan

Product NDC
71626-101
11-digit product format
716260101
Labeler code
71626
Product ID
71626-101_f538eaaa-1f19-4f02-b744-4749e899b54d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medstone Pharma LLC
Application
ANDA207867
Marketing category
ANDA
Marketing start
2018-05-30
Substance
ZOLMITRIPTAN
Active strength
2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN2.5 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
71626-101-06Zolmitriptan1 in 1 BLISTER PACKTABLET, FILM COATED110
71626-101-06Zolmitriptan6 in 1 CARTONTABLET, FILM COATED610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71626-101ZOLMITRIPTAN TABLET, FILM COATED [MEDSTONE PHARMA LLC]10Current NDC, Legacy NDC, 2 package rows20230426_c970dd17-abdb-4fac-8de8-984e388b498c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSNc970dd17-abdb-4fac-8de8-984e388b498c10
200194ZOLMitriptan 5 MG Oral TabletPSNc970dd17-abdb-4fac-8de8-984e388b498c10
200193zolmitriptan 2.5 MG Oral TabletSCDc970dd17-abdb-4fac-8de8-984e388b498c10
200194zolmitriptan 5 MG Oral TabletSCDc970dd17-abdb-4fac-8de8-984e388b498c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71626-101-06716260101066 BLISTER PACK in 1 CARTON (71626-101-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2018-05-300000-00-00NoNoCurrent