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United States · US · US:70518-3822_3f665aca-7ee1-dce4-e063-6394a90a3075

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7051838220
    30 TABLET in 1 BLISTER PACK (70518-3822-0)
  • ndc11
    7051838221
    60 TABLET in 1 BOTTLE, PLASTIC (70518-3822-1)
  • ndc11
    7051838222
    20 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2)
  • ndc11
    7051838223
    30 TABLET in 1 BOTTLE, PLASTIC (70518-3822-3)
  • ndc11
    7051838224
    14 TABLET in 1 BOTTLE, PLASTIC (70518-3822-4)
  • ndc11
    7051838225
    6 TABLET in 1 BLISTER PACK (70518-3822-5)
  • ndc11
    7051838227
    12 TABLET in 1 BOTTLE, PLASTIC (70518-3822-7)

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": "70518-3822_3f665aca-7ee1-dce4-e063-6394a90a3075",
  "productndc": "70518-3822",
  "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": "20230806",
  "active_numerator_strength": "500"
}

Related drugs

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