sumatriptan

Generic: sumatriptan

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan
Generic Name sumatriptan
Labeler caplin steriles limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

sumatriptan succinate 6 mg/.5mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-118
Product ID 65145-118_eeefceae-7dbe-4215-90b2-59b5d509547f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213998
Listing Expiration 2026-12-31
Marketing Start 2024-09-28

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 65145118
Hyphenated Format 65145-118

Supplemental Identifiers

RxCUI
313165
UPC
0365145118011
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
  • 5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01)
source: ndc

Packages (1)

65145-118-05 5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01)

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": "eeefceae-7dbe-4215-90b2-59b5d509547f", "openfda": {"upc": ["0365145118011"], "unii": ["J8BDZ68989"], "rxcui": ["313165"], "spl_set_id": ["01293e09-d49a-411d-9647-6f23318ac201"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (65145-118-05)  / .5 mL in 1 VIAL (65145-118-01)", "package_ndc": "65145-118-05", "marketing_start_date": "20240928"}], "brand_name": "Sumatriptan", "product_id": "65145-118_eeefceae-7dbe-4215-90b2-59b5d509547f", "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": "65145-118", "generic_name": "Sumatriptan", "labeler_name": "Caplin Steriles Limited", "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": "20240928", "listing_expiration_date": "20261231"}