Azilsartan Medoxomil

Orange BookSPL

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

Identification

ManufacturerWilshire Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5253600803
30 TABLET in 1 BOTTLE (52536-008-03)

Annotations

Orange Book

N200796

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": "52536-008_c09103d8-c094-473d-a303-bbb4f334aa8c",
  "productndc": "52536-008",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "200796",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG MEDOXOMIL",
        "product_no": "001",
        "approval_date": "Feb 25, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 80MG MEDOXOMIL",
        "product_no": "002",
        "approval_date": "Feb 25, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZILSARTAN KAMEDOXOMIL",
  "proprietary_name": "Azilsartan Medoxomil",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA200796",
  "marketing_category": "NDA",
  "nonproprietary_name": "Azilsartan kamedoxomil",
  "start_marketing_date": "20260427",
  "active_numerator_strength": "80"
}

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