sumatriptan

Generic: sumatriptan

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan
Generic Name sumatriptan
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

sumatriptan succinate 6 mg/.5mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-804
Product ID 70069-804_53c62307-bd19-4418-b1b0-c0274b5595df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213998
Listing Expiration 2026-12-31
Marketing Start 2021-10-25

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 70069804
Hyphenated Format 70069-804

Supplemental Identifiers

RxCUI
313165
UPC
0370069804018
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 ANDA213998 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70069-804-01) / .5 mL in 1 VIAL
  • 5 VIAL in 1 CARTON (70069-804-05) / .5 mL in 1 VIAL
source: ndc

Packages (2)

70069-804-01 1 VIAL in 1 CARTON (70069-804-01) / .5 mL in 1 VIAL 70069-804-05 5 VIAL in 1 CARTON (70069-804-05) / .5 mL in 1 VIAL

Ingredients (1)

sumatriptan succinate (6 mg/.5mL)

Linked Drug Pages (1)

Sumatriptan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "53c62307-bd19-4418-b1b0-c0274b5595df", "openfda": {"upc": ["0370069804018"], "unii": ["J8BDZ68989"], "rxcui": ["313165"], "spl_set_id": ["53c62307-bd19-4418-b1b0-c0274b5595df"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70069-804-01)  / .5 mL in 1 VIAL", "package_ndc": "70069-804-01", "marketing_start_date": "20211025"}, {"sample": false, "description": "5 VIAL in 1 CARTON (70069-804-05)  / .5 mL in 1 VIAL", "package_ndc": "70069-804-05", "marketing_start_date": "20211025"}], "brand_name": "Sumatriptan", "product_id": "70069-804_53c62307-bd19-4418-b1b0-c0274b5595df", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "70069-804", "generic_name": "Sumatriptan", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sumatriptan", "active_ingredients": [{"name": "SUMATRIPTAN SUCCINATE", "strength": "6 mg/.5mL"}], "application_number": "ANDA213998", "marketing_category": "ANDA", "marketing_start_date": "20211025", "listing_expiration_date": "20261231"}