Enalaprilat

Orange BookSPL

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

Identification

ManufacturerDr. Reddys Laboratories Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359807858
10 VIAL in 1 CARTON (43598-078-58) / 1 mL in 1 VIAL (43598-078-11)

Annotations

Orange Book

A075578

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5d398da1-020c-ccb1-a775-ce8e0b29d621": {
      "match": "brand_token",
      "title": "ENALAPRILAT INJECTION [DR. REDDYS LABORATORIES INC]",
      "spl_version": "6",
      "published_date": "2024-06-10"
    }
  },
  "productid": "43598-078_d20e2c0a-b04d-5e4a-a28b-442e0a77f3b6",
  "productndc": "43598-078",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "075578",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.25MG/ML",
        "product_no": "001",
        "approval_date": "Aug 22, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENALAPRILAT",
  "proprietary_name": "Enalaprilat",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075578",
  "marketing_category": "ANDA",
  "nonproprietary_name": "enalaprilat",
  "start_marketing_date": "20230606",
  "active_numerator_strength": "1.25"
}

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