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United States · US · US:69729-123_0d811063-82c1-bf9f-e063-6294a90aa371

PROXEN NP 660

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 3

  • ndc11
    6972912312
    1 BLISTER PACK in 1 CARTON (69729-123-12) / 12 TABLET in 1 BLISTER PACK
  • ndc11
    6972912324
    2 BLISTER PACK in 1 CARTON (69729-123-24) / 12 TABLET in 1 BLISTER PACK
  • ndc11
    6972912350
    50 POUCH in 1 CARTON (69729-123-50) / 2 TABLET in 1 POUCH

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A091353
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": {
    "09990b2f-202e-b4df-e063-6394a90a055b": {
      "match": "brand_token",
      "title": "PROXEN NP 660 (NAPROXEN SODIUM) TABLET [OPMX LLC]",
      "spl_version": "3",
      "published_date": "2023-12-28"
    }
  },
  "productid": "69729-123_0d811063-82c1-bf9f-e063-6294a90aa371",
  "productndc": "69729-123",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091353",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "PROXEN NP 660",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091353",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20231107",
  "active_numerator_strength": "220"
}

Related drugs

Other records sharing ATC code G02CC02.

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