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United States · US · US:85766-105_5031fb96-af96-4e50-e063-6394a90a8c08

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 9

  • ndc11
    8576610500
    1000 TABLET in 1 BOTTLE (85766-105-00)
  • ndc11
    8576610501
    100 TABLET in 1 BOTTLE (85766-105-01)
  • ndc11
    8576610505
    500 TABLET in 1 BOTTLE (85766-105-05)
  • ndc11
    8576610510
    10 TABLET in 1 BOTTLE (85766-105-10)
  • ndc11
    8576610514
    14 TABLET in 1 BOTTLE (85766-105-14)
  • ndc11
    8576610520
    20 TABLET in 1 BOTTLE (85766-105-20)
  • ndc11
    8576610530
    30 TABLET in 1 BOTTLE (85766-105-30)
  • ndc11
    8576610560
    60 TABLET in 1 BOTTLE (85766-105-60)
  • ndc11
    8576610590
    90 TABLET in 1 BOTTLE (85766-105-90)

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": "85766-105_5031fb96-af96-4e50-e063-6394a90a8c08",
  "productndc": "85766-105",
  "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": "20200301",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code G02CC02.

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