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United States · US · US:42571-133_3afc5367-562f-b4a0-e063-6294a90a2560

Diclofenac Sodium/Misoprostol

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4257113329
    60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    4257113330
    30 TABLET in 1 BOTTLE (42571-133-30)
  • ndc11
    4257113360
    60 TABLET in 1 BOTTLE (42571-133-60)
  • ndc11
    4257113390
    90 TABLET in 1 BOTTLE (42571-133-90)

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": "42571-133_3afc5367-562f-b4a0-e063-6294a90a2560",
  "productndc": "42571-133",
  "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": "50; 200"
}

Related drugs

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