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United States · US · US:70121-1686_b5cc060b-1669-4bee-b0f7-911b5d188547

Exenatide

Orange BookUNIISPLATC A10BJ01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeA10BJ01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012116861
    1 CARTRIDGE in 1 CARTON (70121-1686-1) / 2.4 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
9P1872D4OL
EXENATIDE
RxCUI 60548
Orange Book
A206697
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9P1872D4OL",
    "rxcui": "60548",
    "inchikey": null,
    "display_name": "EXENATIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "e6cb5c8f-e97f-4a6a-95a4-939fd2393949": {
      "match": "brand_token",
      "title": "EXENATIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "16",
      "published_date": "2026-01-12"
    }
  },
  "productid": "70121-1686_b5cc060b-1669-4bee-b0f7-911b5d188547",
  "productndc": "70121-1686",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206697",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MCG/1.2ML (250MCG/ML)",
        "product_no": "001",
        "approval_date": "Nov 19, 2024"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "600MCG/2.4ML (250MCG/ML)",
        "product_no": "002",
        "approval_date": "Nov 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EXENATIDE",
  "proprietary_name": "Exenatide",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA206697",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Exenatide",
  "start_marketing_date": "20241122",
  "active_numerator_strength": "250"
}

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