IRBESARTAN

Orange BookUNIISPLATC C09CA04

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeC09CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4670844130
30 TABLET in 1 BOTTLE (46708-441-30)
ndc11
4670844131
100 TABLET in 1 BOTTLE (46708-441-31)
ndc11
4670844171
500 TABLET in 1 BOTTLE (46708-441-71)
ndc11
4670844190
90 TABLET in 1 BOTTLE (46708-441-90)
ndc11
4670844191
1000 TABLET in 1 BOTTLE (46708-441-91)

Annotations

UNII (FDA Substance ID)

J0E2756Z7N

IRBESARTAN

RxCUI 83818

Orange Book

A091236

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "J0E2756Z7N",
    "rxcui": "83818",
    "inchikey": "YOSHYTLCDANDAN-UHFFFAOYSA-N",
    "display_name": "IRBESARTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "85494404-484c-45a1-8487-f9eb2a76490d": {
      "match": "brand_token",
      "title": "IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "46708-441_2efa4733-b806-42ee-b587-cae816493fa7",
  "productndc": "46708-441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091236",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Oct 15, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Oct 15, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IRBESARTAN",
  "proprietary_name": "IRBESARTAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091236",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IRBESARTAN",
  "start_marketing_date": "20160701",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code C09CA04.

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