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United States · US · US:16714-891_c5920565-605b-45cb-8da9-4d418ec3b356

Sumatriptan and Naproxen Sodium

Orange BookUNIISPLATC G02CC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeG02CC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1671489101
    9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A202803
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "65147b04-0b6b-4d30-9710-d5cdce85e8f5": {
      "match": "brand_token",
      "title": "SUMATRIPTAN INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "16714-891_c5920565-605b-45cb-8da9-4d418ec3b356",
  "productndc": "16714-891",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202803",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 85MG BASE",
        "product_no": "001",
        "approval_date": "Jul 20, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE",
  "proprietary_name": "Sumatriptan and Naproxen Sodium",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202803",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sumatriptan and Naproxen Sodium",
  "start_marketing_date": "20181127",
  "active_numerator_strength": "500; 85"
}

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