NAPROXEN

Orange BookUNIISPLATC G02CC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDIRECT RX

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7218913614
14 TABLET in 1 BOTTLE (72189-136-14)
ndc11
7218913620
20 TABLET in 1 BOTTLE (72189-136-20)
ndc11
7218913630
30 TABLET in 1 BOTTLE (72189-136-30)
ndc11
7218913660
60 TABLET in 1 BOTTLE (72189-136-60)
ndc11
7218913671
100 TABLET in 1 BOTTLE (72189-136-71)
ndc11
7218913690
90 TABLET in 1 BOTTLE (72189-136-90)

Annotations

UNII (FDA Substance ID)

57Y76R9ATQ

NAPROXEN

RxCUI 7258

Orange Book

A091416

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": "72189-136_2be91642-ea9b-b147-e063-6394a90a2d96",
  "productndc": "72189-136",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091416",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 14, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Feb 14, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Feb 14, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "NAPROXEN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091416",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NAPROXEN",
  "start_marketing_date": "20201015",
  "active_numerator_strength": "500"
}

Related drugs

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