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United States · US · US:58602-735_b14dd7e8-b43c-4d9e-9609-13d9f30a74c4

Naproxen Sodium HEADACHE PAIN

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 · 7

  • ndc11
    5860273507
    1 BOTTLE in 1 CARTON (58602-735-07) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273519
    1 BOTTLE in 1 CARTON (58602-735-19) / 90 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273521
    1 BOTTLE in 1 CARTON (58602-735-21) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273529
    1 BOTTLE in 1 CARTON (58602-735-29) / 150 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273538
    1 BOTTLE in 1 CARTON (58602-735-38) / 300 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273540
    1 BOTTLE in 1 CARTON (58602-735-40) / 500 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5860273578
    1 BOTTLE in 1 CARTON (58602-735-78) / 50 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": "58602-735_b14dd7e8-b43c-4d9e-9609-13d9f30a74c4",
  "productndc": "58602-735",
  "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 HEADACHE PAIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205497",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20210714",
  "active_numerator_strength": "220"
}

Related drugs

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