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United States · US · US:66267-153_1f98cfb6-fa4d-2288-e063-6294a90a4de7

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    6626715310
    10 TABLET in 1 BOTTLE (66267-153-10)
  • ndc11
    6626715314
    14 TABLET in 1 BOTTLE (66267-153-14)
  • ndc11
    6626715315
    15 TABLET in 1 BOTTLE (66267-153-15)
  • ndc11
    6626715320
    20 TABLET in 1 BOTTLE (66267-153-20)
  • ndc11
    6626715330
    30 TABLET in 1 BOTTLE (66267-153-30)
  • ndc11
    6626715340
    40 TABLET in 1 BOTTLE (66267-153-40)
  • ndc11
    6626715342
    42 TABLET in 1 BOTTLE (66267-153-42)
  • ndc11
    6626715360
    60 TABLET in 1 BOTTLE (66267-153-60)
  • ndc11
    6626715390
    90 TABLET in 1 BOTTLE (66267-153-90)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A078250
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": "66267-153_1f98cfb6-fa4d-2288-e063-6294a90a4de7",
  "productndc": "66267-153",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078250",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Mar 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Mar 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078250",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen",
  "start_marketing_date": "20070701",
  "active_numerator_strength": "500"
}

Related drugs

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