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United States · US · US:58602-738_3d89b39b-8273-4715-91b1-7a8bccb458d8

Naproxen Sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 11

  • ndc11
    5860273807
    1 BOTTLE in 1 CARTON (58602-738-07) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273812
    1 BOTTLE in 1 CARTON (58602-738-12) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273814
    1 BOTTLE in 1 CARTON (58602-738-14) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273819
    1 BOTTLE in 1 CARTON (58602-738-19) / 90 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273821
    1 BOTTLE in 1 CARTON (58602-738-21) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273825
    1 BOTTLE in 1 CARTON (58602-738-25) / 130 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273829
    1 BOTTLE in 1 CARTON (58602-738-29) / 150 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273834
    1 BOTTLE in 1 CARTON (58602-738-34) / 200 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273838
    300 TABLET, FILM COATED in 1 BOTTLE (58602-738-38)
  • ndc11
    5860273840
    500 TABLET, FILM COATED in 1 BOTTLE (58602-738-40)
  • ndc11
    5860273844
    400 TABLET, FILM COATED in 1 BOTTLE (58602-738-44)

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": "58602-738_3d89b39b-8273-4715-91b1-7a8bccb458d8",
  "productndc": "58602-738",
  "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": "20160318",
  "active_numerator_strength": "220"
}

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