zolmitriptan

Generic: zolmitriptan

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolmitriptan
Generic Name zolmitriptan
Labeler padagis israel pharmaceuticals ltd
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

zolmitriptan 5 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-711
Product ID 45802-711_670da414-66ad-4c5f-b218-f4958daae12c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212469
Listing Expiration 2026-12-31
Marketing Start 2021-11-16

Pharmacologic Class

Established (EPC)
serotonin-1b and serotonin-1d receptor agonist [epc]
Mechanism of Action
serotonin 1b receptor agonists [moa] serotonin 1d receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802711
Hyphenated Format 45802-711

Supplemental Identifiers

RxCUI
402000
UNII
2FS66TH3YW
NUI
N0000175763 N0000175764 N0000175765

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zolmitriptan (source: ndc)
Generic Name zolmitriptan (source: ndc)
Application Number ANDA212469 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)
source: ndc

Packages (1)

45802-711-91 6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)

Ingredients (1)

zolmitriptan (5 mg/1)

Linked Drug Pages (1)

zolmitriptan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "670da414-66ad-4c5f-b218-f4958daae12c", "openfda": {"nui": ["N0000175763", "N0000175764", "N0000175765"], "unii": ["2FS66TH3YW"], "rxcui": ["402000"], "spl_set_id": ["24e12658-eb42-4d1f-9192-9c4298416d51"], "pharm_class_epc": ["Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "pharm_class_moa": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE, SPRAY in 1 CARTON (45802-711-91)  / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)", "package_ndc": "45802-711-91", "marketing_start_date": "20211116"}], "brand_name": "zolmitriptan", "product_id": "45802-711_670da414-66ad-4c5f-b218-f4958daae12c", "dosage_form": "SPRAY", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "45802-711", "generic_name": "zolmitriptan", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "zolmitriptan", "active_ingredients": [{"name": "ZOLMITRIPTAN", "strength": "5 mg/1"}], "application_number": "ANDA212469", "marketing_category": "ANDA", "marketing_start_date": "20211116", "listing_expiration_date": "20261231"}