Back to search
🇺🇸

United States · US · US:71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b

Diclofenac Sodium/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
    7133526031
    20 TABLET in 1 BOTTLE (71335-2603-1)
  • ndc11
    7133526032
    14 TABLET in 1 BOTTLE (71335-2603-2)
  • ndc11
    7133526033
    60 TABLET in 1 BOTTLE (71335-2603-3)
  • ndc11
    7133526034
    30 TABLET in 1 BOTTLE (71335-2603-4)
  • ndc11
    7133526035
    10 TABLET in 1 BOTTLE (71335-2603-5)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A204355
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": "71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b",
  "productndc": "71335-2603",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204355",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;0.2MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;0.2MG",
        "product_no": "002",
        "approval_date": "Jul 15, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
  "proprietary_name": "Diclofenac Sodium/Misoprostol",
  "active_ingred_unit": "mg/1; ug/1",
  "application_number": "ANDA204355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium/Misoprostol",
  "start_marketing_date": "20210901",
  "active_numerator_strength": "75; 200"
}

Related drugs

Other records sharing ATC code D11AX.

Access this data programmatically

Query Diclofenac Sodium/Misoprostol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.