Azilsartan medoxomil

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074823706
30 TABLET in 1 BOTTLE (70748-237-06)

Annotations

Orange Book

A214489

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "b1c8de43-3b26-408f-8c7e-6c7d76348199": {
      "match": "brand_token",
      "title": "AZILSARTAN MEDOXOMIL TABLET [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2026-05-14"
    }
  },
  "productid": "70748-237_f05aba4d-376f-460f-9264-ecf267e04dcd",
  "productndc": "70748-237",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214489",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG MEDOXOMIL",
        "product_no": "001",
        "approval_date": "Jul 20, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG MEDOXOMIL",
        "product_no": "002",
        "approval_date": "Jul 20, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZILSARTAN KAMEDOXOMIL",
  "proprietary_name": "Azilsartan medoxomil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214489",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azilsartan medoxomil",
  "start_marketing_date": "20260514",
  "active_numerator_strength": "80"
}

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