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United States · US · US:65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373

Fosinopril Sodium and Hydrochlorothiazide

Orange BookUNIISPLATC C09AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC09AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6586230901
    100 TABLET in 1 BOTTLE (65862-309-01)
  • ndc11
    6586230930
    30 TABLET in 1 BOTTLE (65862-309-30)
  • ndc11
    6586230999
    1000 TABLET in 1 BOTTLE (65862-309-99)

Annotations

UNII (FDA Substance ID)
NW2RTH6T2N
FOSINOPRIL SODIUM
RxCUI 227278
Orange Book
A079245
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NW2RTH6T2N",
    "rxcui": "227278",
    "inchikey": "TVTJZMHAIQQZTL-WATAJHSMSA-M",
    "display_name": "FOSINOPRIL SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ff1323cc-7ad8-488d-94a7-a11555db78a7": {
      "match": "brand_token",
      "title": "FOSINOPRIL SODIUM TABLET [CHARTWELL RX, LLC]",
      "spl_version": "4",
      "published_date": "2025-11-17"
    }
  },
  "productid": "65862-309_34bf0456-37d0-4d7d-a585-1555b7bc9373",
  "productndc": "65862-309",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "079245",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;12.5MG",
        "product_no": "001",
        "approval_date": "Jul 9, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;12.5MG",
        "product_no": "002",
        "approval_date": "Jul 9, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Fosinopril Sodium and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079245",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fosinopril Sodium and Hydrochlorothiazide",
  "start_marketing_date": "20090709",
  "active_numerator_strength": "20; 12.5"
}

Related drugs

Other records sharing ATC code C09AA.

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