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United States · US · US:51013-137_9a223804-f229-442b-85a9-7f0f8fd74ba1

NAPROXEN SODIUM

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerPuraCap Pharmaceutical LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5101313715
    1 BOTTLE in 1 CARTON (51013-137-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    5101313728
    1 BOTTLE in 1 CARTON (51013-137-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    5101313760
    160 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-137-60)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A208363
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": {
    "c5146d73-2f34-4dfe-ac29-97071279dc4d": {
      "match": "brand_token",
      "title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "51013-137_9a223804-f229-442b-85a9-7f0f8fd74ba1",
  "productndc": "51013-137",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "208363",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Mar 15, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "NAPROXEN SODIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208363",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20180320",
  "active_numerator_strength": "220"
}

Related drugs

Other records sharing ATC code G02CC02.

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