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United States · US · US:71205-060_6b4c9ec2-308f-4b60-941c-34a2c7a7882c

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7120506014
    14 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-14)
  • ndc11
    7120506015
    15 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-15)
  • ndc11
    7120506020
    20 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-20)
  • ndc11
    7120506030
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-30)
  • ndc11
    7120506040
    40 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-40)
  • ndc11
    7120506045
    45 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-45)
  • ndc11
    7120506060
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-60)
  • ndc11
    7120506090
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-90)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A091432
ABAB
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": "71205-060_6b4c9ec2-308f-4b60-941c-34a2c7a7882c",
  "productndc": "71205-060",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "091432",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "001",
        "approval_date": "Sep 19, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091432",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen",
  "start_marketing_date": "20160705",
  "active_numerator_strength": "375"
}

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