sumatriptan and naproxen sodium

Generic: sumatriptan and naproxen sodium

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sumatriptan and naproxen sodium
Generic Name sumatriptan and naproxen sodium
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naproxen sodium 500 mg/1, sumatriptan succinate 85 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-891
Product ID 16714-891_c5920565-605b-45cb-8da9-4d418ec3b356
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202803
Listing Expiration 2026-12-31
Marketing Start 2018-11-27

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc] 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 16714891
Hyphenated Format 16714-891

Supplemental Identifiers

RxCUI
849450
UPC
0316714891019
UNII
9TN87S3A3C 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 and naproxen sodium (source: ndc)
Generic Name sumatriptan and naproxen sodium (source: ndc)
Application Number ANDA202803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 85 mg/1
source: ndc
Packaging
  • 9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01)
source: ndc

Packages (1)

Ingredients (2)

naproxen sodium (500 mg/1) sumatriptan succinate (85 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c5920565-605b-45cb-8da9-4d418ec3b356", "openfda": {"upc": ["0316714891019"], "unii": ["9TN87S3A3C", "J8BDZ68989"], "rxcui": ["849450"], "spl_set_id": ["3f2ec27e-0e96-4028-a1fa-114e6d501464"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01)", "package_ndc": "16714-891-01", "marketing_start_date": "20181127"}], "brand_name": "Sumatriptan and Naproxen Sodium", "product_id": "16714-891_c5920565-605b-45cb-8da9-4d418ec3b356", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "16714-891", "generic_name": "Sumatriptan and Naproxen Sodium", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sumatriptan and Naproxen Sodium", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "500 mg/1"}, {"name": "SUMATRIPTAN SUCCINATE", "strength": "85 mg/1"}], "application_number": "ANDA202803", "marketing_category": "ANDA", "marketing_start_date": "20181127", "listing_expiration_date": "20261231"}