sumatriptan

Generic: sumatriptan

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan
Generic Name sumatriptan
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sumatriptan succinate 100 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-346
Product ID 69452-346_025c1199-46e1-4e03-8489-8a24a0834891
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078284
Listing Expiration 2026-12-31
Marketing Start 2022-02-18

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 69452346
Hyphenated Format 69452-346

Supplemental Identifiers

RxCUI
313160 313161 315223
UNII
J8BDZ68989

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 ANDA078284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69452-346-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-346-60)
source: ndc

Packages (1)

69452-346-72 1 BLISTER PACK in 1 CARTON (69452-346-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-346-60)

Ingredients (1)

sumatriptan succinate (100 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": "025c1199-46e1-4e03-8489-8a24a0834891", "openfda": {"unii": ["J8BDZ68989"], "rxcui": ["313160", "313161", "315223"], "spl_set_id": ["e90b0eea-c424-4f00-98da-6ed6e80de1f6"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-346-72)  / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-346-60)", "package_ndc": "69452-346-72", "marketing_start_date": "20220218"}], "brand_name": "Sumatriptan", "product_id": "69452-346_025c1199-46e1-4e03-8489-8a24a0834891", "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": "69452-346", "generic_name": "Sumatriptan", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sumatriptan", "active_ingredients": [{"name": "SUMATRIPTAN SUCCINATE", "strength": "100 mg/1"}], "application_number": "ANDA078284", "marketing_category": "ANDA", "marketing_start_date": "20220218", "listing_expiration_date": "20261231"}