Zolmitriptan

Product NDC
62332-463
11-digit product format
623320463
Labeler code
62332
Product ID
62332-463_e476239f-aad2-4fa7-8413-cfbe80600697
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204232
Marketing category
ANDA
Marketing start
2024-01-10
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
Zolmitriptan
Listing expiration
2026-12-31

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
62332-463-03Zolmitriptan3 in 1 CARTONTABLET, FILM COATED32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-463-03EA - Each62332-46396ab0f16-50cf-40ec-bb21-be6bb46f1c4612024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-463ZOLMITRIPTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240113_cd6203d4-02b5-43b2-9460-16a4d932ed51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSNcd6203d4-02b5-43b2-9460-16a4d932ed512
200194ZOLMitriptan 5 MG Oral TabletPSNcd6203d4-02b5-43b2-9460-16a4d932ed512
200193zolmitriptan 2.5 MG Oral TabletSCDcd6203d4-02b5-43b2-9460-16a4d932ed512
200194zolmitriptan 5 MG Oral TabletSCDcd6203d4-02b5-43b2-9460-16a4d932ed512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-463-03623320463033 TABLET, FILM COATED in 1 CARTON (62332-463-03) 2024-01-10NoNoCurrent