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United States · US · US:71335-0095_59c90ed3-0908-4977-bb00-7f102e6d7aff

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 · 9

  • ndc11
    7133500951
    20 TABLET in 1 BOTTLE (71335-0095-1)
  • ndc11
    7133500952
    30 TABLET in 1 BOTTLE (71335-0095-2)
  • ndc11
    7133500953
    40 TABLET in 1 BOTTLE (71335-0095-3)
  • ndc11
    7133500954
    120 TABLET in 1 BOTTLE (71335-0095-4)
  • ndc11
    7133500955
    60 TABLET in 1 BOTTLE (71335-0095-5)
  • ndc11
    7133500956
    90 TABLET in 1 BOTTLE (71335-0095-6)
  • ndc11
    7133500957
    14 TABLET in 1 BOTTLE (71335-0095-7)
  • ndc11
    7133500958
    15 TABLET in 1 BOTTLE (71335-0095-8)
  • ndc11
    7133500959
    21 TABLET in 1 BOTTLE (71335-0095-9)

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": "71335-0095_59c90ed3-0908-4977-bb00-7f102e6d7aff",
  "productndc": "71335-0095",
  "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": "375"
}

Related drugs

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