sumatriptan

Generic: sumatriptan

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan
Generic Name sumatriptan
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

sumatriptan succinate 6 mg/.5mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-289
Product ID 36000-289_62c6c207-3e07-498e-ac5c-2f6e1a632a7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207101
Listing Expiration 2027-12-31
Marketing Start 2023-01-19

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 36000289
Hyphenated Format 36000-289

Supplemental Identifiers

RxCUI
313165
UPC
0336000289016
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 ANDA207101 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.5mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (36000-289-25) / .5 mL in 1 VIAL
source: ndc

Packages (3)

36000-289-05 5 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIAL 36000-289-10 10 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIAL 36000-289-25 25 VIAL in 1 CARTON (36000-289-25) / .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": "62c6c207-3e07-498e-ac5c-2f6e1a632a7e", "openfda": {"upc": ["0336000289016"], "unii": ["J8BDZ68989"], "rxcui": ["313165"], "spl_set_id": ["d13df081-648c-44c0-9854-5a1bfe23ae89"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (36000-289-05)  / .5 mL in 1 VIAL", "package_ndc": "36000-289-05", "marketing_start_date": "20230119"}, {"sample": false, "description": "10 VIAL in 1 CARTON (36000-289-10)  / .5 mL in 1 VIAL", "package_ndc": "36000-289-10", "marketing_start_date": "20230119"}, {"sample": false, "description": "25 VIAL in 1 CARTON (36000-289-25)  / .5 mL in 1 VIAL", "package_ndc": "36000-289-25", "marketing_start_date": "20230119"}], "brand_name": "Sumatriptan", "product_id": "36000-289_62c6c207-3e07-498e-ac5c-2f6e1a632a7e", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "36000-289", "generic_name": "Sumatriptan", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sumatriptan", "active_ingredients": [{"name": "SUMATRIPTAN SUCCINATE", "strength": "6 mg/.5mL"}], "application_number": "ANDA207101", "marketing_category": "ANDA", "marketing_start_date": "20230119", "listing_expiration_date": "20271231"}