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United States · US · US:51655-743_4ba9ffdd-00a3-39ed-e063-6394a90ab827

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 4

  • ndc11
    5165574320
    20 TABLET in 1 BOTTLE, PLASTIC (51655-743-20)
  • ndc11
    5165574325
    60 TABLET in 1 BOTTLE, PLASTIC (51655-743-25)
  • ndc11
    5165574326
    90 TABLET in 1 BOTTLE, PLASTIC (51655-743-26)
  • ndc11
    5165574352
    30 TABLET in 1 BOTTLE, PLASTIC (51655-743-52)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A212517
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "57Y76R9ATQ",
    "rxcui": "7258",
    "inchikey": "CMWTZPSULFXXJA-VIFPVBQESA-N",
    "display_name": "NAPROXEN",
    "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": "51655-743_4ba9ffdd-00a3-39ed-e063-6394a90ab827",
  "productndc": "51655-743",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212517",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen",
  "start_marketing_date": "20210629",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code G02CC02.

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