Naproxen Sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5860281907
1 BOTTLE in 1 CARTON (58602-819-07) / 24 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281914
1 BOTTLE in 1 CARTON (58602-819-14) / 50 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281919
1 BOTTLE in 1 CARTON (58602-819-19) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281921
1 BOTTLE in 1 CARTON (58602-819-21) / 100 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281929
1 BOTTLE in 1 CARTON (58602-819-29) / 150 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281938
1 BOTTLE in 1 CARTON (58602-819-38) / 300 TABLET, FILM COATED in 1 BOTTLE
ndc11
5860281940
1 BOTTLE in 1 CARTON (58602-819-40) / 500 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

A205497

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "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": "58602-819_915208d0-ee3a-4b1f-9c3c-76d9cb8362c9",
  "productndc": "58602-819",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205497",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Mar 18, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20171211",
  "active_numerator_strength": "220"
}

Related drugs

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