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United States · US · US:47335-410_c67d3234-28c7-40a9-a472-87747bb4242a

Sumatriptan and Naproxen Sodium

Orange BookUNIISPLATC G02CC

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG02CC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4733541022
    9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22)
  • ndc11
    4733541083
    30 TABLET, FILM COATED in 1 BOTTLE (47335-410-83)
  • ndc11
    4733541088
    100 TABLET, FILM COATED in 1 BOTTLE (47335-410-88)

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": "47335-410_c67d3234-28c7-40a9-a472-87747bb4242a",
  "productndc": "47335-410",
  "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": "20180720",
  "active_numerator_strength": "500; 85"
}

Related drugs

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