Benicar

Orange BookUNIISPLATC C09CA08

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC09CA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0713086030
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0860-30)

Annotations

UNII (FDA Substance ID)

6M97XTV3HD

OLMESARTAN MEDOXOMIL

RxCUI 118463

Orange Book

N021286

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6M97XTV3HD",
    "rxcui": "118463",
    "inchikey": "UQGKUQLKSCSZGY-UHFFFAOYSA-N",
    "display_name": "OLMESARTAN MEDOXOMIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a90915ca-f9d3-4fff-8370-d5dc4cdfc521": {
      "match": "brand_token",
      "title": "BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0713-0860_00494313-514a-b3b5-e063-6294a90a5ad5",
  "productndc": "0713-0860",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021286",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 25, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Apr 25, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Apr 25, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLMESARTAN MEDOXOMIL",
  "proprietary_name": "Benicar",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021286",
  "marketing_category": "NDA",
  "nonproprietary_name": "olmesartan medoxomil",
  "start_marketing_date": "20220901",
  "active_numerator_strength": "5"
}

Related drugs

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