sumatriptan

Generic: sumatriptan

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan
Generic Name sumatriptan
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sumatriptan succinate 50 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0475
Product ID 80425-0475_2aab828f-48fd-5ff9-e063-6394a90ac966
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078284
Listing Expiration 2026-12-31
Marketing Start 2024-12-30

Pharmacologic Class

Classes
serotonin 1b receptor agonists [moa] serotonin 1d receptor agonists [moa] serotonin-1b and serotonin-1d receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250475
Hyphenated Format 80425-0475

Supplemental Identifiers

RxCUI
313161
UNII
J8BDZ68989

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 ANDA078284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (80425-0475-1) / 9 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

80425-0475-1 1 BLISTER PACK in 1 CARTON (80425-0475-1) / 9 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

sumatriptan succinate (50 mg/1)

Linked Drug Pages (1)

Sumatriptan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2aab828f-48fd-5ff9-e063-6394a90ac966", "openfda": {"unii": ["J8BDZ68989"], "rxcui": ["313161"], "spl_set_id": ["2aab8786-b225-833a-e063-6394a90ac7ae"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80425-0475-1)  / 9 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "80425-0475-1", "marketing_start_date": "20241230"}], "brand_name": "Sumatriptan", "product_id": "80425-0475_2aab828f-48fd-5ff9-e063-6394a90ac966", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "80425-0475", "generic_name": "Sumatriptan", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sumatriptan", "active_ingredients": [{"name": "SUMATRIPTAN SUCCINATE", "strength": "50 mg/1"}], "application_number": "ANDA078284", "marketing_category": "ANDA", "marketing_start_date": "20241230", "listing_expiration_date": "20261231"}