sumatriptan

Generic: sumatriptan

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

Drug Facts

Product Profile

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

sumatriptan 20 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-598
Product ID 45802-598_d1aeb8e8-e726-405a-bf9d-7436af66c48b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213465
Listing Expiration 2027-12-31
Marketing Start 2020-10-04

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 45802598
Hyphenated Format 45802-598

Supplemental Identifiers

RxCUI
313159 314227
UNII
8R78F6L9VO
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 sumatriptan (source: ndc)
Generic Name sumatriptan (source: ndc)
Application Number ANDA213465 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00)
source: ndc

Packages (1)

45802-598-06 6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00)

Ingredients (1)

sumatriptan (20 mg/1)

Linked Drug Pages (1)

SUMATRIPTAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "d1aeb8e8-e726-405a-bf9d-7436af66c48b", "openfda": {"nui": ["N0000175763", "N0000175764", "N0000175765"], "unii": ["8R78F6L9VO"], "rxcui": ["313159", "314227"], "spl_set_id": ["6d521807-e5ce-498d-a224-5534c5ea61fa"], "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 CONTAINER in 1 CARTON (45802-598-06)  / 1 SPRAY in 1 CONTAINER (45802-598-00)", "package_ndc": "45802-598-06", "marketing_start_date": "20201004"}], "brand_name": "SUMATRIPTAN", "product_id": "45802-598_d1aeb8e8-e726-405a-bf9d-7436af66c48b", "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": "45802-598", "generic_name": "sumatriptan", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUMATRIPTAN", "active_ingredients": [{"name": "SUMATRIPTAN", "strength": "20 mg/1"}], "application_number": "ANDA213465", "marketing_category": "ANDA", "marketing_start_date": "20201004", "listing_expiration_date": "20271231"}