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United States · US · US:55111-134_8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1b

Enalapril maleate and hydrochlorothiazide

Orange BookUNIISPLATC C09AA

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeC09AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5511113401
    100 TABLET in 1 BOTTLE (55111-134-01)
  • ndc11
    5511113410
    1000 TABLET in 1 BOTTLE (55111-134-10)

Annotations

UNII (FDA Substance ID)
9O25354EPJ
ENALAPRIL MALEATE
RxCUI 203123
Orange Book
A075909
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9O25354EPJ",
    "rxcui": "203123",
    "inchikey": "OYFJQPXVCSSHAI-QFPUQLAESA-N",
    "display_name": "ENALAPRIL MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c1e4cd79-ece5-432c-bd3a-ed4633ccec70": {
      "match": "brand_token",
      "title": "ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "55111-134_8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1b",
  "productndc": "55111-134",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075909",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;12.5MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;25MG",
        "product_no": "002",
        "approval_date": "Oct 15, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "Enalapril maleate and hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA075909",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Enalapril maleate and hydrochlorothiazide",
  "start_marketing_date": "20011015",
  "active_numerator_strength": "10; 25"
}

Related drugs

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