Diclofenac Sodium

Orange BookSPL

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

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5860260621
1 KIT in 1 CARTON (58602-606-21) * 2 TUBE in 1 KIT / 150 g in 1 TUBE * 1 TUBE in 1 KIT / 50 g in 1 TUBE

Annotations

Orange Book

A204306

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "86461915-9bc1-43d4-8d92-6eef3e56bd90": {
      "match": "brand_token",
      "title": "DICLOFENAC POTASSIUM TABLET, COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "58602-606_aa7e21b9-c07f-48a6-9266-67a490fd2b8b",
  "productndc": "58602-606",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204306",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "May 6, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "Diclofenac Sodium",
  "active_ingred_unit": null,
  "application_number": "ANDA204306",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac sodium",
  "start_marketing_date": "20230510",
  "active_numerator_strength": null
}

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