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United States · US · US:43598-977_affe6a89-16fb-8b78-d0db-1f7f8a818ea7

DICLOFENAC SODIUM

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4359897705
    1 TUBE in 1 CARTON (43598-977-05) / 50 g in 1 TUBE
  • ndc11
    4359897710
    1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE
  • ndc11
    4359897715
    1 TUBE in 1 CARTON (43598-977-15) / 150 g in 1 TUBE
  • ndc11
    4359897721
    2 TUBE in 1 CARTON (43598-977-21) / 100 g in 1 TUBE
  • ndc11
    4359897722
    1 TUBE in 1 CARTON (43598-977-22) / 20 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A210986
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "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": "43598-977_affe6a89-16fb-8b78-d0db-1f7f8a818ea7",
  "productndc": "43598-977",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "210986",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Jan 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "DICLOFENAC SODIUM",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA210986",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium topical gel, 1%",
  "start_marketing_date": "20200914",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB55.

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