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United States · US · US:71335-0345_54192467-cd41-453a-9f0b-8cfa5c7b805b

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133503450
    28 TABLET in 1 BOTTLE (71335-0345-0)
  • ndc11
    7133503451
    30 TABLET in 1 BOTTLE (71335-0345-1)
  • ndc11
    7133503452
    60 TABLET in 1 BOTTLE (71335-0345-2)
  • ndc11
    7133503453
    10 TABLET in 1 BOTTLE (71335-0345-3)
  • ndc11
    7133503454
    90 TABLET in 1 BOTTLE (71335-0345-4)
  • ndc11
    7133503455
    20 TABLET in 1 BOTTLE (71335-0345-5)
  • ndc11
    7133503456
    120 TABLET in 1 BOTTLE (71335-0345-6)
  • ndc11
    7133503457
    14 TABLET in 1 BOTTLE (71335-0345-7)
  • ndc11
    7133503458
    42 TABLET in 1 BOTTLE (71335-0345-8)
  • ndc11
    7133503459
    40 TABLET in 1 BOTTLE (71335-0345-9)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A075927
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": "71335-0345_54192467-cd41-453a-9f0b-8cfa5c7b805b",
  "productndc": "71335-0345",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075927",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Dec 18, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Dec 18, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Dec 18, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075927",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen",
  "start_marketing_date": "20100218",
  "active_numerator_strength": "500"
}

Related drugs

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