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United States · US · US:68788-7090_ae19d4cf-db8f-4859-bf83-57c074f30215

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 9

  • ndc11
    6878870901
    100 TABLET in 1 BOTTLE (68788-7090-1)
  • ndc11
    6878870902
    20 TABLET in 1 BOTTLE (68788-7090-2)
  • ndc11
    6878870903
    30 TABLET in 1 BOTTLE (68788-7090-3)
  • ndc11
    6878870904
    40 TABLET in 1 BOTTLE (68788-7090-4)
  • ndc11
    6878870905
    15 TABLET in 1 BOTTLE (68788-7090-5)
  • ndc11
    6878870906
    60 TABLET in 1 BOTTLE (68788-7090-6)
  • ndc11
    6878870907
    14 TABLET in 1 BOTTLE (68788-7090-7)
  • ndc11
    6878870908
    120 TABLET in 1 BOTTLE (68788-7090-8)
  • ndc11
    6878870909
    90 TABLET in 1 BOTTLE (68788-7090-9)

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": "68788-7090_ae19d4cf-db8f-4859-bf83-57c074f30215",
  "productndc": "68788-7090",
  "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": "20180129",
  "active_numerator_strength": "500"
}

Related drugs

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