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United States · US · US:70709-102_97662326-3312-4ed1-9036-77e250e34cda

AAGYLUR

Orange BookUNIISPLATC M01CC01

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

Identification

ManufacturerCycle Pharmaceuticals Ltd.
CountryUS (United States)
ATC codeM01CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070910210
    100 CAPSULE in 1 BOTTLE (70709-102-10)

Annotations

UNII (FDA Substance ID)
GNN1DV99GX
PENICILLAMINE
RxCUI 7975
Orange Book
A213293
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GNN1DV99GX",
    "rxcui": "7975",
    "inchikey": "VVNCNSJFMMFHPL-VKHMYHEASA-N",
    "display_name": "PENICILLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ddbd84a9-1c39-42e0-a271-138784e1dc58": {
      "match": "brand_token",
      "title": "AAGYLUR (PENICILLAMINE) CAPSULE [CYCLE PHARMACEUTICALS LTD.]",
      "spl_version": "1",
      "published_date": "2025-09-29"
    }
  },
  "productid": "70709-102_97662326-3312-4ed1-9036-77e250e34cda",
  "productndc": "70709-102",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213293",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLAMINE",
  "proprietary_name": "AAGYLUR",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213293",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Penicillamine",
  "start_marketing_date": "20250925",
  "active_numerator_strength": "250"
}

Related drugs

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