FDA.reportPublic FDA data

ZOMIG

Product NDC
60846-133
11-digit product format
608460133
Labeler code
60846
Product ID
60846-133_dc410bf4-cff9-473c-95f1-4b0412bf05f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207867
Marketing category
ANDA
Marketing start
2023-01-09
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FS66TH3YW
Rxcui153353, 200193, 200194, 213167

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60846-133-60ZOMIG1 in 1 CARTONTABLET, FILM COATED11
60846-133-60ZOMIG3 in 1 BLISTER PACKTABLET, FILM COATED31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60846-133-60EA - Each60846-1331819b6e8-121e-4497-a7d1-426ec6e1f45c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60846-133ZOMIG (ZOLMITRIPTAN) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240216_1d977430-f494-415d-9daf-3c3163156249.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSN1d977430-f494-415d-9daf-3c31631562491
200194ZOLMitriptan 5 MG Oral TabletPSN1d977430-f494-415d-9daf-3c31631562491
153353Zomig 2.5 MG Oral TabletPSN1d977430-f494-415d-9daf-3c31631562491
213167Zomig 5 MG Oral TabletPSN1d977430-f494-415d-9daf-3c31631562491
153353zolmitriptan 2.5 MG Oral Tablet [Zomig]SBD1d977430-f494-415d-9daf-3c31631562491
213167zolmitriptan 5 MG Oral Tablet [Zomig]SBD1d977430-f494-415d-9daf-3c31631562491
200193zolmitriptan 2.5 MG Oral TabletSCD1d977430-f494-415d-9daf-3c31631562491
200194zolmitriptan 5 MG Oral TabletSCD1d977430-f494-415d-9daf-3c31631562491
153353Zomig 2.5 MG Oral TabletSY1d977430-f494-415d-9daf-3c31631562491
213167Zomig 5 MG Oral TabletSY1d977430-f494-415d-9daf-3c31631562491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60846-133-60608460133601 BLISTER PACK in 1 CARTON (60846-133-60) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-01-09NoNoCurrent