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United States · US · US:71335-1183_3c1e7d73-b9c0-4260-87ed-049797c1e8dc

Diclofenac Sodium and Misoprostol

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133511831
    20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-1)
  • ndc11
    7133511832
    14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-2)
  • ndc11
    7133511833
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-3)
  • ndc11
    7133511834
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-4)
  • ndc11
    7133511835
    10 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-5)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A203995
ABAB
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": "ORAL",
  "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": "71335-1183_3c1e7d73-b9c0-4260-87ed-049797c1e8dc",
  "productndc": "71335-1183",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "203995",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;0.2MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;0.2MG",
        "product_no": "002",
        "approval_date": "Nov 25, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
  "proprietary_name": "Diclofenac Sodium and Misoprostol",
  "active_ingred_unit": "mg/1; ug/1",
  "application_number": "ANDA203995",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium and Misoprostol",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "75; 200"
}

Related drugs

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