Nintedanib Capsules, 100 mg and 150 mg

Orange BookUNIISPLATC L01EX09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEXELAN PHARMACEUTICALS INC.

CountryUS (United States)

ATC codeL01EX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7628278760
60 CAPSULE in 1 BOTTLE (76282-787-60)

Annotations

UNII (FDA Substance ID)

42F62RTZ4G

NINTEDANIB ESYLATE

RxCUI 1592736

Orange Book

A212609

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "42F62RTZ4G",
    "rxcui": "1592736",
    "inchikey": "MMMVNAGRWOJNMW-FJBFXRHMSA-N",
    "display_name": "NINTEDANIB ESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "60d8104e-cb6c-4f4f-8159-95ed57346ffa": {
      "match": "brand_token",
      "title": "NINTEDANIB CAPSULES, 100 MG AND 150 MG (NINTEDANIB) CAPSULE [EXELAN PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2026-05-11"
    }
  },
  "productid": "76282-787_e6cab487-5092-4b7b-a3c2-da94f6dc66c2",
  "productndc": "76282-787",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Apr 2, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Apr 2, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NINTEDANIB ESYLATE",
  "proprietary_name": "Nintedanib Capsules, 100 mg and 150 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nintedanib",
  "start_marketing_date": "20260507",
  "active_numerator_strength": "150"
}

Related drugs

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