sumatriptan and naproxen sodium (65862-928)

Drug Facts

Product Profile

Brand Name sumatriptan and naproxen sodium

Generic Name sumatriptan and naproxen sodium

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-928

Product ID 65862-928_b0441826-19e2-4113-89b7-727a2b882a09

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207457

Listing Expiration 2026-12-31

Marketing Start 2018-02-15

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 65862928

Hyphenated Format 65862-928

Supplemental Identifiers

RxCUI

849450

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 ANDA207457 (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 (65862-928-36)

source: ndc

Packages (1)

65862-928-36 9 TABLET, FILM COATED in 1 BOTTLE (65862-928-36)

Ingredients (2)

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

Linked Drug Pages (1)

Sumatriptan and Naproxen Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "b0441826-19e2-4113-89b7-727a2b882a09", "openfda": {"unii": ["9TN87S3A3C", "J8BDZ68989"], "rxcui": ["849450"], "spl_set_id": ["f5203c66-0a40-4263-a237-b71e930e4697"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 TABLET, FILM COATED in 1 BOTTLE (65862-928-36)", "package_ndc": "65862-928-36", "marketing_start_date": "20180215"}], "brand_name": "Sumatriptan and Naproxen Sodium", "product_id": "65862-928_b0441826-19e2-4113-89b7-727a2b882a09", "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": "65862-928", "generic_name": "Sumatriptan and Naproxen Sodium", "labeler_name": "Aurobindo Pharma Limited", "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": "ANDA207457", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20261231"}